SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND ...
FDA Recall #Z-0531-2026 — Class I — October 9, 2025
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.
Recalling Firm
Glycar SA Pty., Ltd. — Irene, N/A
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
30 units
Distribution
US
Code Information
UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated