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Glycar SA Pty., Ltd. recalls SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PT
Recalled December 3, 2025 · FDA recall Z-0532-2026 · Glycar SA Pty
Hazard
The impacted lot may not meet the required tensile strength specification. · FDA Class I
Units
18 units
Sold at
US
Description
The impacted lot may not meet the required tensile strength specification.
Product
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Manufacturer(s)
Glycar SA Pty., Ltd.
Made in
South Africa
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →