United StatesSJM Pericardial Patch with EnCap Technology in sizes 9×14 cm (Model REF C0914, UDI/DI 05414734007276, lots T2502257 exp. 2028-01-28 and T2505144 exp. 2028-04-11; 30 units) and 5×10 cm (Model REF C0510, UDI/DI 05414734007269, lot T2506245 exp. 2028-05-25; 18 units), described as PATCH, PLEDGET AND INTRACARDIAC (PETP, PTFE, POLYPROPYLENE), sold in the U.S. These lots are being recalled because they may not meet the required tensile strength specification.
What's being recalled
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Recalling firm: Glycar SA Pty., Ltd., Irene, N/A, South Africa.
How to identify it
UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11 UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
The hazard
The impacted lot may not meet the required tensile strength specification.
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
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)