FDAHealthOctober 9, 2025
Glycar SA Pty., Ltd. — SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
⚠️ The impacted lot may not meet the required tensile strength specification.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- October 9, 2025
US
What's affected?
- Product
- SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
- Brand
- Glycar SA Pty., Ltd.
- Lot code
- T2502257
Additional details
UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 30 units.
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