Recalls That Should Be on Your Radar—Week of February 3, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Food Safety Recalls:

Q’s American Best Trading Inc. Issues Recall for Siluriformes Products Without Benefit of Import Inspection

Q's American Best Trading Inc., a Lakewood, Calif. firm and the importer of record, is recalling approximately 1,008 pounds of imported Siluriformes fish products that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen Siluriformes, specifically Sheat fish, items were imported from Vietnam to the U.S. on Dec. 25, 2018. These items were shipped to retail locations in California. The problem was discovered on Jan. 29, 2019 during FSIS surveillance activities of imported products at the distributor facility.

For more information on this recall, check out the USDA’s recall statement.

Richwell Group, Inc. Issues Recall for Siluriformes Products Without Benefit of Import Inspection

Richwell Group, Inc., doing business as Maxfield Seafood, a City of Industry, Calif. firm and the importer of record, is recalling approximately 55,300 pounds of Siluriformes fish products that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen Siluriformes items, specifically Sheat fish, were imported from Vietnam to the United States on various dates from April 2018 through December 2018. The products have a shelf life of two years.

These items were shipped to retail locations nationwide. The problem was discovered on Jan. 30, 2019 during FSIS surveillance activities of imported products at the distributor facility.

For a list of recalled products, check out the USDA’s news release.

Pilgrim’s Pride Corporation Issues Recall for Chicken Products Due to Possible Contamination With Rubber

Pilgrim’s Pride Corporation, a Mt. Pleasant, Texas establishment, is recalling approximately 58,020 pounds of not-ready-to-eat (NRTE) breaded chicken products that may be contaminated with extraneous materials, specifically rubber, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, not-ready-to-eat (NRTE) breaded chicken items were produced on Jan. 4, 2019.

The products subject to recall bear establishment number “P-7091A” inside the USDA mark of inspection. These items were shipped to Publix Super Markets in Florida for deli food service use.

The problem was discovered on Jan. 30, 2019 when the company was informed by Publix Super Markets’ employees about a consumer complaint regarding white rubber in the products.

To read more about this recall, consult the USDA’s statement.

Medical Device and Product Recalls:

Stryker Launches “Field Action for LIFEPAK Defibrillators

Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 Monitor/Defibrillators.

The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include an update to the firmware for a component on the System Printed Circuit Board Assembly. Stryker anticipates that all devices subject to this field action will be serviced by December 31, 2019. If a customer experiences this issue, they should contact Stryker as soon as possible at 1 800 442 1142 and selecting option 7.

To learn more about this recall, check out the company’s statement.

Edwards Lifesciences Recalls Swan-Ganz Catheters

Edwards Lifesciences is recalling 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured December 26, 2017, to April 19, 2018 due, to incorrect assembly and reversal of the catheter tubes (lumens). If the lumens are reversed the clinician may note inaccurate pulmonary artery and central venous pressure values and waveforms. This may result in unintended treatment, which may result in adverse health consequences.

The inaccurate waveforms and pressure values may also misguide a physician during placement of the catheter, increasing the risk of blood vessel perforation. This exposes the patient to a reasonable likelihood of a serious adverse health consequence or death.

Read more about this Class I recall here.

Dr. Reddy’s Laboratories Issues Recall of Levetiracetam Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

The recall, which began in October 2018, was originally initiated due to a product complaint received for mislabeling. The pre-printed text content on the infusion bag (primary container) for the lot indicates product information as Levetiracetam in 0.75% Sodium Chloride Injection (1000mg/100ml). The label on the external foil pouch has the product information as Levetiracetam in 0.54% Sodium Chloride Injection (1500mg/100ml). To date, there have been no reports of adverse events related to this recall.

For additional information on this recall check out the recall announcement.

FDA Issues Letter to Providers on Breast Implant Associated Anaplastic Large Cell Lymphoma

The Food and Drug Administration (FDA) wants to increase awareness about an association between all breast implants, regardless of filling or texture, and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant.

We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy. We are also asking health care providers to report to the FDA cases of BIA-ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.

Read the full letter here.