Recalls That Should Be on Your Radar—Week of January 13, 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:

Perdue Foods LLC, Recalls Gluten Free Chicken Nuggets Due to Possible Contamination with Wood

Perdue Foods, LLC, a Perry, Ga. establishment, is recalling approximately 68,244 pounds of ready-to-eat chicken nugget products that may be contaminated with extraneous materials, specifically wood, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat chicken nugget items were produced on Oct. 25, 2018.

The product subject to recall bears establishment number “P-33944” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

The problem was discovered when the firm received three consumer complaints that wood was found in the product. A complaint was also reported to FSIS’ consumer complaint monitoring system. FSIS was notified by the firm on Jan. 17, 2019.

There have been no confirmed reports of adverse reactions due to consumption of these products.

For details about recalled products, check out the recall statement.

Johnsonville, LLV Recalls Pork Patty Products Due to Potential Contamination with Black Rubber

Johnsonville, LLC, a Sheboygan Falls, Wis. establishment, is recalling approximately 48,371 pounds of raw ground pork patty products that may be contaminated with extraneous materials, specifically black rubber, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The raw ground frozen pork patties were produced and packaged on Sept. 27, 2018, Oct. 17, 2018 and Oct. 18, 2018.

The problem was discovered when the firm received three consumer complaints regarding black rubber in the product. FSIS was notified on Jan. 17, 2019.

There have been no confirmed reports of adverse reactions due to consumption of these products.

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

Medical Device and Product Recalls:

Medtronic Recalls Synergy Cranial Software Due to Inaccuracies Displayed During Procedures

Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm.

The Synergy Cranial Software and StealthStation S7 Cranial Software, used with the StealthStation Surgical Navigation System, provides detailed three-dimensional (3D) images of a patient's brain to help neurosurgeons safely navigate surgical tools and implants used during brain surgery.

During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.

To learn more about this software recall, consult the MedWatch statement.

FDA Statements

FDA Issues Letter on Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Stent

The FDA recommends that health care providers:

• Continue surveillance of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents per the current standard of care.
• In clinical decision-making, discuss the risks and benefits of all available treatment options for PAD with your patients.
• Report any adverse events or suspected adverse events experienced with the use of paclitaxel-coated balloons and paclitaxel-eluting stents. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Read the full letter to providers here.