Device product
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Z-1394-2024
Product summary
- Event
- Event 94181
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 206,200 kits
- Official record key
device-enforcement:Z-1394-2024
Official wording
Reason: The kits contain saline flush syringes which were recalled by the supplier.
Code information: Lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.
Distribution pattern: US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.
Derived failure modes
-
Unknown
The kits contain saline flush syringes which were recalled by the supplier.