SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | High |
| Status | ongoing |
| Recall date | October 09, 2025 |
| Reported | December 03, 2025 |
| Recalling firm | Glycar SA Pty., Ltd. |
| Country / region | South Africa N/A |
Hazard
The impacted lot may not meet the required tensile strength specification.
Affected products
- SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
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