FDA-Device2025-12-03Class I
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Glycar SA Pty., Ltd.
Hazard
The impacted lot may not meet the required tensile strength specification.
Sold states
US
Affected count
18 units
Manufactured in
1 Albert Road, box 967, Irene, N/A, South Africa
Products
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2026Don't want to check this manually?
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