Z-0531-2026 Class I Ongoing
FDA device recall Z-0531-2026 was initiated by Glycar SA Pty., Ltd. on October 9, 2025 and is designated Class I. Reason for recall: The impacted lot may not meet the required tensile strength specification. The recall status is ongoing. Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Reason for Recall
The impacted lot may not meet the required tensile strength specification.
Distribution Pattern
US
Code Information
UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11