Device product
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Z-0400-2022
Product summary
- Event
- Event 89046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 620 tube sets
- Official record key
device-enforcement:Z-0400-2022
Official wording
Reason: This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
Code information: Lot code 20519-2103
Distribution pattern: NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
Derived failure modes
-
Sterility assurance
non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile