Device product
Halyard, Drape Pack. Kit Code: LMDP36-01.
Z-2409-2026
Product summary
- Event
- Event 99021
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 72 kits
- Official record key
device-enforcement:Z-2409-2026
Official wording
Reason: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Code information: Kit Code: LMDP36-01.UDI-DI: 10809160479148. Lot Number: LMDP36-01. Expiration Date: 9/10/2028
Distribution pattern: US Nationwide distribution in the state of Iowa.
Derived failure modes
-
Unknown
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.