Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
This recall has been terminated (originally issued October 28, 2021).
- Recall Initiated
- October 28, 2021
- Terminated
- August 7, 2023
- Recall Number
- Z-0400-2022
- Quantity
- 620 tube sets
- Firm Location
- Peachtree Corners, GA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
Lot / Code Info
Lot code 20519-2103
Root Cause
Employee error
Action Taken
Stradis Healthcare immediately contacted all 28 customers via email and/or phone between 10/28/21 and 10/29/21. The firm has requested the return of the units.
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