Patch Recall: Glycar SJM Pericardial, EnCap 9x14cm REF C0914
The FDA recall concerns the SJM Pericardial Patch with EnCap Technology (9x14 cm), Model REF C0914, from Glycar. The impacted lot may not meet the required tensile strength specification. 30 units distributed in the US are involved; recall number is UDI/DI 05414734007276; affected lots are T2502257 (exp. 20280128) and T2505144 (exp. 2028.04.11).
| Brand | Glycar SA Pty., Ltd. |
|---|---|
| Product | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Reason | The impacted lot may not meet the required tensile strength specification. |
| Severity | critical |
| Units affected | 18 |
| Distribution | US |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use recalled patches from the affected lots.
- If you possess one, contact your healthcare provider for guidance and possible replacement.
- Check the lot numbers (T2502257 or T2505144) and recall number to confirm if your device is affected.
- Follow supplier or FDA instructions to return, exchange, or dispose of the product.
How to identify the recalled item
| Lot / date codes | UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11 |
|---|---|
| Lot / date codes | UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.