Device product
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Z-2221-2024
Product summary
- Firm
- ASPEN SURGICAL
- Event
- Event 94778
- Status
- Completed
- Classification
- Class II
- Quantity
- 1900 units
- Official record key
device-enforcement:Z-2221-2024
Official wording
Reason: The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
Code information: UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982
Distribution pattern: US Nationwide
Derived failure modes
-
Sterility assurance
sterile barrier may be compromised