FDA-Device2025-12-03Class IPROCESSING DEFECT
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
OTHERNationwide distribution
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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