Device product
Surgicare Neuro Pack - Neurological Kit
Z-0862-2022
Product summary
- Event
- Event 89671
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 176 units
- Official record key
device-enforcement:Z-0862-2022
Official wording
Reason: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code information: SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545
Distribution pattern: US Nationwide distribution in the states of IN, TX, and PA.
Derived failure modes
-
Sterility assurance
bag may be perforated or torn, which may result in a breach in the sterility