SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Reported: December 3, 2025 Initiated: October 9, 2025 #Z-0532-2026
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.
Details
- Recalling Firm
- Glycar SA Pty., Ltd.
- Units Affected
- 18 units
- Distribution
- US
- Location
- Irene, N/A
Frequently Asked Questions
What product was recalled? ▼
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE. Recalled by Glycar SA Pty., Ltd.. Units affected: 18 units.
Why was this product recalled? ▼
The impacted lot may not meet the required tensile strength specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2025. Severity: Critical. Recall number: Z-0532-2026.
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