FDA-Device2025-12-03Class IPROCESSING DEFECT
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Hazard
The impacted lot may not meet the required tensile strength specification.
Intended for
Adults
Illnesses reported
None reported
Sold states
US
Affected count
30 units
Manufactured in
1 Albert Road, box 967, Irene, N/A, South Africa
Products
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2026Want us to check the next one for you?
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