Home / Recalls / Glycar SA Pty., Ltd. / Z-0531-2026

Z-0531-2026 Class I Ongoing

Recalled by Glycar SA Pty., Ltd. — Irene, N/A

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