Device product
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Z-0921-2026
Product summary
- Event
- Event 98066
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-0921-2026
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: DYND04000, UDI-DI: 10193489191349(each), 20193489191346(case), Lot Number: 2023102590
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