SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND...
FDA Recall #Z-0532-2026 — Class I — October 9, 2025
Product Description
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; 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
18 units
Distribution
US
Code Information
UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated