Device product
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Z-1668-2022
Product summary
- Event
- Event 90749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1306 kits
- Official record key
device-enforcement:Z-1668-2022
Official wording
Reason: Procedure packs contained a recalled product.
Code information: NS CVR PREP PACK /89-6817.09; Lots 56391514 (exp 08/01/2023), 56926777 (exp 08/01/2023), 57103035 (exp. 08/01/2023); UDI-DI (GTIN): 00749756730938 NON-STERILE IR ADMISSION KIT / 89-8762.05; Lot 57104020 (exp 07/01/2023); UDI-DI (GTIN): 00749756883627
Distribution pattern: US Nationwide distribution in the states of OH and TN.
Derived failure modes
-
Unknown
Procedure packs contained a recalled product.