Device product
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Z-0722-2025
Product summary
- Event
- Event 95806
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 kits
- Official record key
device-enforcement:Z-0722-2025
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: 10193489789935(each), 40193489789936(case); Lot Number: 20JBD814
Distribution pattern: US Nationwide. Canada.
Derived failure modes
-
Potency or specification failure
out-of-specification