Device product
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Z-0719-2025
Product summary
- Event
- Event 95806
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 kits
- Official record key
device-enforcement:Z-0719-2025
Official wording
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Code information: UDI-DI: 10195327589202(each), 40195327589203(case); Lot Number: 24CMH776
Distribution pattern: US Nationwide. Canada.
Derived failure modes
-
Potency or specification failure
out-of-specification