United StatesCytal Wound Matrix and Cytal Burn Matrix products from Integra LifeSciences are being recalled: Cytal Wound Matrix 2‑Layer 5x5 cm (Product ID WSM0505, UDI‑DI 00386190001431), 2‑Layer 7x10 cm (WSM0710, UDI‑DI 00386190001448), 2‑Layer 10x15 cm (WSM1015, UDI‑DI 00386190001455), and Cytal Burn Matrix 7x10 cm (BMM0710, UDI‑DI 00386190001103) and 10x15 cm (BMM1015, UDI‑DI 00386190001110) with multiple listed lot numbers. They were recalled due to an increased rate of out-of-specification endotoxin results.
What's being recalled
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States.
How to identify it
Product ID: WSM0505. UDI-DI: 00386190001431. Lot Numbers: 7579683, 7583933, 7583891, 7583935, 7594266, 7594286, 7593011. Product ID: WSM0710. UDI-DI: 00386190001448. Lot Numbers: 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, 7593013. Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935, 7594266, 7593018, 7594288, 7594284, 7593013. Product ID: BMM0710. UDI-DI: 00386190001103. Lot Numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, 7593013. Product ID: BMM1015. UDI-DI: 00386190001110. Lot Numbers: 7579681, 7582225, 7582227, 7583933, 7591942, 7591944, 7583935, 7593018, 7594284, 7593013.
The hazard
Increased rate of out-of-specification endotoxin results.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)