Device product
Lum Lam Custom Pack - Anesthesia Kit
Z-0863-2022
Product summary
- Event
- Event 89671
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-0863-2022
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 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685
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