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Glycar SA Pty., Ltd. recalls SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTF
Recalled December 3, 2025 · FDA recall Z-0531-2026 · Glycar SA Pty
Hazard
The impacted lot may not meet the required tensile strength specification. · FDA Class I
Units
30 units
Sold at
US
Description
The impacted lot may not meet the required tensile strength specification.
Product
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; 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 →