- CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device’s infusion sets (FDA Recall Number: Z-1442-2020).Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.
CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market. The following is a summary of each individual product recall details:
CMEAmerica BodyGuard® Infusion Pump Recall Details
On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall.
CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator’s Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.
To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic:
- Use of products in the field in accordance with the Operator’s Manual and the additional mitigations outlined in the updated customer letter;
- Product service and repair activities at CME America and Authorized Service Depots; and
- Supply of infusion sets and accessories to support the infusion pumps remaining in the field.
The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient’s body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient’s vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.
The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress
*Note: These two pump models were inadvertently left out of the initial customer notification
CMEAmerica BodyGuard® Microset Infusion Set Recall Details
On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers.
To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company’s September recall announcement to customers.
Affected products include:
- CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.
Customer inquiries related to either recall, as well as adverse reaction/events experienced with the product should be addressed to CME America Support Center at 877-263-0111.
- GSK Consumer Healthcare is voluntarily recalling five lots (listed below) of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be present in the product. There is a potential risk of choking or physical injury to the soft tissues of the mouth or gastrointestinal tract of a consumer using the product who may not see a broken piece or shaving of plastic cap.These lots were distributed from October 28, 2019 through January 21, 2020 within the United States to retail stores and online retailers nationwide. The recall is limited to the five lots listed below:
| Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872 Lot: MP8B (EXP Sep2021) |
Benefiber Prebiotic Fiber Supplement, 500G UPC 886790218302 Lots: YT2Y (EXP Oct2021) 7D6E (EXP Nov2021) |
Benefiber Prebiotic Fiber Supplement, 760G UPC 8886790211907 Lots: UV5C (EXP Oct2021) 648H (EXP Nov2021) |
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As of the date of the recall announcement, GSK Consumer Healthcare has received one consumer complaint of a green particle observed inside a bottle of product.
Patient safety and product quality are our utmost priorities at GSK Consumer Healthcare.
GSK Consumer Healthcare is taking all appropriate steps to notify its retail and wholesale customers impacted by this recall and is arranging for return of all recalled products.
Consumers that have Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder in their possession are advised to check the lot information on the product to see if it is part of the five lots being recalled. If the consumer finds that they have a recalled product, they should stop use immediately.
For information on the recall, to request a refund on recalled products, to report an adverse experience or for any other inquiries regarding Benefiber, consumers can call the GSK Contact Center at 1-800-452-0051, Monday – Friday, 8:00am – 6:00pm EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
- SUGAR LAND, Texas, April 23, 2020 — QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi. Fresenius Kabi recalled multiple lots of Ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials.QuVa has reached out to all hospital pharmacy customers who purchased product from the lots affected and has asked them to: quarantine anything that is in stock to prevent use in direct patient care; complete a return response form to capture the amount of unused product; and return the finished goods to QuVa for destruction.Listed below are the recalled lots distributed directly to hospital pharmacies between February 13, 2020 and April 21, 2020.
| Product Description |
Product Code |
Lot Numbers |
| R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50ml in Sodium Chloride—60ml BD syringe |
70092-1433-50 |
30009563, 30009539, 30009489, 30009412, 30009413, 30009411, 30009410, 30009388, 30009387, 30009228, 30009227, 30009139, 30009138, 30009074, 30009073, 30008949, 30008859, 30008861, 30008554, 30008198, 30008721 |
Customers with questions about the recall can email QuVa at QuVaRecallApril2020@Quvapharma.com or contact QuVa Pharma Customer Service at 888.339.0874
- Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:
| NDC No. |
Description |
Lot |
Expiration Date |
| 60846-301-15 |
Nizatidine Oral Solution |
06598004A |
04/2020 |
| 60846-301-15 |
Nizatidine Oral Solution |
06599001A |
12/2020 |
| 60846-301-15 |
Nizatidine Oral Solution |
06599002A |
12/2020 |
The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA.
Amnealis notifying its direct customers by mailing (FED Ex Standard Overnight) a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.
Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com for further information. Consumers should contact their physician or other healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.
Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease. We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA). These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening.We have reviewed case reports in the FDA Adverse Event Reporting System database, the published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines. These adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death. We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available.BACKGROUND: Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine is also FDA-approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.Hydroxychloroquine and chloroquine:
- should be used for COVID-19 only when patients can be appropriately monitored in the hospital as required by the EUA or are enrolled in a clinical trial with appropriate screening and monitoring. FDA is reviewing the safety of their use when used outside of the setting of hospitalized patients for whom use was authorized.
- have not been shown to be safe and effective for treating or preventing COVID-19.
- are being studied in clinical trials for COVID-19, and FDA authorized their temporary use during the COVID-19 pandemic under limited circumstances through the EUA, and not through regular FDA approval.
- being used under the EUA when supplied from the Strategic National Stockpile, the national repository of critical medical supplies to be used during public health emergencies.
- can cause abnormal heart rhythms such as QT interval prolongation
- can cause dangerously rapid heart rate called ventricular tachycardia.
- pose risks that may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition.
- should be used with caution in Patients who also have other health issues such as heart and kidney disease, who are likely to be at increased risk of these heart problems when receiving these medicines.
RECOMMENDATION:
- Patients taking hydroxychloroquine or chloroquine for FDA-approved indications to treat malaria or autoimmune conditions should continue taking their medicine as prescribed.
- The benefits of these medicines outweigh the risks at the recommended doses for these conditions.
Do not stop taking your medicine without first talking to your health care professional and talk to them if you have any questions or concerns
Be aware that there are no proven treatments for COVID-19 and no vaccine. If you are receiving hydroxychloroquine or chloroquine for COVID-19 and experience irregular heartbeats, dizziness, or fainting, seek medical attention right away by calling 911.
- Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials.Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the shortterm (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days.Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:
|
Product Name/Product size
|
NDC Number
|
Product Code
|
Batch Number
|
Expiration Date
|
First Ship Date
|
Last Ship Date
|
| Ketorolac Tromethamine Injection, USP, 30 mg / mL, 1 mL fill in a 2 mL amber vial |
63323-162-01
|
160201
|
6118737 |
04/2020 |
05/30/2018 |
06/27/2018 |
| 6118902 |
04/2020 |
08/01/2018 |
08/15/2018 |
| 6119052 |
05/2020 |
06/25/2018 |
07/25/2018 |
| 6119752 |
08/2020 |
09/28/2018 |
12/06/2018 |
| 6122349 |
07/2021 |
09/16/2019 |
11/04/2019 |
| 6122538 |
09/2021 |
11/01/2019 |
12/16/2019 |
| Ketorolac Tromethamine Injection, USP, 60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial |
63323-162-02 |
160202 |
6119229 |
06/2020 |
08/09/2018 |
10/30/2018 |
| 6119273 |
06/2020 |
09/26/2018 |
03/30/2019 |
| 6119843 |
09/2020 |
11/11/2019 |
01/07/2020 |
| 6121115 |
02/2021 |
03/30/2019 |
04/22/2019 |
| 6121451 |
03/2021 |
04/29/2019 |
08/05/2019 |
| 6121452 |
03/2021 |
07/12/2019 |
10/22/2019 |
| 6121496 |
03/2021 |
06/21/2019 |
12/10/2019 |
Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updatesExternal Link Disclaimer.
Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.The company has determined that one (1) isolated TRUE METRIX AIR Blood Glucose Meter was packaged into a TRUE METRIX Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death.There is one (1) affected TRUE METRIX AIR meter with serial number TA1548753 that was packaged into a TRUE METRIX Blood Glucose Meter Kit with the Lot number KW0135 and with UDI # (01)00021292006075(17)200831(10)KW0135(21)TA1548753. It has been determined that this kit was distributed nationwide in the United States in February 2019. Trividia Health has not received any reports of patient injury or an adverse event related to this voluntary recall.Consumers who have or may have the TRUE METRIX AIR meter should do the following:
- Check to confirm if you have the affected TRUE METRIX AIR meter by obtaining the meter serial number (TA1548753) from the serial number label located on the back of the meter, and then visit www.TrividiaHealth.com/air-product-noticeExternal Link Disclaimer or call Trividia Health toll-free at 1-800-518-5726, Monday-Friday, 8AM-8PM EST.
- If you have the affected TRUE METRIX AIR meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the affected TRUE METRIX AIR meter at no charge.
- Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.
Notifications will be sent to US pharmacies, durable medical equipment providers and distributors who may have received this device from Trividia’s customer.
Patient safety is a top priority at Trividia Health. The company has notified the U.S. Food and Drug Administration (FDA) of this voluntary product recall and is working with the customer who received the affected meter to quickly resolve this matter.
Users within the USA may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online or by phone.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.
| Product |
NDC Number |
Lot No |
Expiry Date |
| Tetracycline HCl Capsules 250 mg 100 count |
23155-017-01 |
H190666 |
JUL 2022 |
| Tetracycline HCl Capsules 500 mg 100 count |
23155-018-01 |
G190609 |
JUN 2022 |
| Tetracycline HCl Capsules 500 mg 100 count |
23155-018-01 |
G190610 |
JUN 2022 |
| Tetracycline HCl Capsules 500 mg 100 count |
23155-018-01 |
G190611 |
JUN 2022 |
| Tetracycline HCl Capsules 500 mg 100 count |
23155-018-01 |
L191027 |
NOV 2022 |
| Tetracycline HCl Capsules 500 mg 100 count |
23155-018-01 |
L191028 |
NOV 2022 |
| Tetracycline HCl Capsules 500 mg 100 count |
23155-018-01 |
K190953 |
OCT 2022 |
| Tetracycline HCl Capsules 500 mg 100 count |
23155-018-01 |
K190952 |
OCT 2022 |
These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results.
Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.
Tetracycline HCl Capsules USP, 250 mg and 500 mg are indicated in the treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, as adjunctive therapy in severe acne. The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors Nationwide in United States between August 2019 and March 2020.
Avet is notifying its distributors and customers by a separate notification to distributors and through Qualanex and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product.
Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341. Monday – Friday, 8:00 am – 5:00 pm, EST and or recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening. Patients should not stop taking clopidogrel without talking to their prescribing physician. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman. Simvastatin occasionally causes myopathy which is a disease of the muscles. Finally, allergic reactions are also possible and could also be life threatening. International Laboratories, LLC also reports that to date, no complaints have been received related to this event detailing medical illnesses or harmful effects.Clopidogrel Tablets USP 75 mg are a platelet inhibitor (blood thinner) indicated for the use in patient with acute coronary syndrome, recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke.The product was distributed nationwide and delivered to the distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and distributed to retail stores in all US States.International Laboratories, LLC is notifying distributors and customers by letter and is arranging for return of all recalled products. Consumers who have purchased this product should stop using and return the product to the location of purchase for a full refund. For questions regarding return of product please call Inmar at 855-258-7280 or via email internationallabs@inmar.com or by using mailing address Recall Coordinator 635 Vine St. Winston Salem, NC 27101 Inmar’s business hours are (Monday – Friday 9 AM – 5 PM EST).Consumers should also contact their physician or healthcare provider if they are experiencing any health concerns that may be related to taking or using this drug product.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- Conagra Brands, Inc., a Russellville, Ark. establishment, is recalling approximately 130,763 pounds of not ready-to-eat chicken bowl products because the product may contain extraneous material, specifically small rocks, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The frozen, not-ready-to-eat chicken bowl items were produced on Jan. 23, 2020. The following products are subject to recall: [View Labels (PDF Only)]
9.5-oz. cartons containing “Healthy Choice POWER BOWLS Chicken Feta & Farro” with lot code 5006002320, UPC code 072655001800 and a best by date of 10/19/2020 on the label.
9.5-oz. cartons containing “Healthy Choice POWER BOWLS Chicken Feta & Farro, BOILS ÈNERGIE Poulet feta et épeautre” with lot code 5006002320, UPC code 072655003026 and a best by date of 10/19/2020 on the label.
The products subject to recall bear establishment number “P115” printed on the packaging next to the lot code. These items were shipped to retail locations nationwide and exported to Canada.
The problem was discovered when the firm received consumer complaints about rocks being in the products and the firm then notified FSIS of the issue.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away.
FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at http://www.fsis.usda.gov/recalls.
Consumers with questions about the recall or seeking a refund can contact Conagra Brands Consumer Care at 1-800-672-8240 or at Consumer.Care@conagra.com. Member of the media with questions about the recall can contact Daniel Hare, Conagra Brands Senior Director of Communication, at (312) 549-5355.
- Recalled Product
LeMaitre Over the Wire Embolectomy Catheter
Catalog Numbers and Lot Numbers: See full list
Manufacturing Dates : May 5, 2014 to July 17, 2019
Distribution Dates: November 7, 2014 to March 5, 2020
Devices Recalled in the U.S.: 49,393
Date Initiated by Firm: March 10, 2020 Who May be Affected
Shelley v. Kraemer was a landmark Supreme Court case which stated that courts could not enforce racial covenants on real estate properties.
TOPIC: LIFEPAK 15 Monitor/Defibrillators by Stryker: Recall – Due to failure to deliver a defibrillation shock after the “Shock” button on the keypad is pressedBACKGROUND: LIFEPAK 15 is a complete acute cardiac care response system designed for basic life support and advanced life support patient management protocols.ISSUE: Stryker is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed. This is a result of oxidation that may have formed over time within the “Shock” button.Stryker is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad. Stryker anticipates that all devices subject to this field action will be serviced by June 2021.RECOMMENDATION: Stryker is instructing customers to continue to use their LIFEPAK 15 monitor/defibrillator according to the operating instructions until the correction can be completed. Customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK- COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the LIFEPAK 15 monitor/defibrillator Operator’s Checklist, number 7).Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Margaret Mitchell’s Gone with the Wind, one of the best-selling novels of all time and the basis for a blockbuster 1939 movie, is published on this day in 1936.In 1926, Mitchell was forced to quit her job as a reporter at the Atlanta Journal to recover from a series of physical injuries. With too much time on her hands, Mitchell soon grew restless. Working on a Remington typewriter, a gift from her second husband, John R. Marsh, in their cramped one-bedroom apartment, Mitchell began telling the story of an Atlanta belle named Pansy O’Hara.In tracing Pansy’s tumultuous life from the antebellum South through the Civil War and into the Reconstruction era, Mitchell drew on the tales she had heard from her parents and other relatives, as well as from Confederate war veterans she had met as a young girl. While she was extremely secretive about her work, Mitchell eventually gave the manuscript to Harold Latham, an editor from New York’s MacMillan Publishing. Latham encouraged Mitchell to complete the novel, with one important change: the heroine’s name. Mitchell agreed to change it to Scarlett, now one of the most memorable names in the history of literature.
