Device product
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Z-0922-2026
Product summary
- Event
- Event 98066
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53 units
- Official record key
device-enforcement:Z-0922-2026
Official wording
Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Code information: DYNJ04048, UDI-DI: 10193489195248(each), 20193489195245(case), Lot Number: 2023112290
Distribution pattern: US Nationwide distribution in the states CA, CO, IL, KS, and MI.
Derived failure modes
-
Labeling or packaging
weak packaging
-
Sterility assurance
breach of sterility