Recall Z-0400-2022 ยท FPA Set, Administration, Intravascular
Stradis Medical, LLC dba Stradis Healthcare
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
| Date | Oct 28, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 620 tube sets |
| Distribution | NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993463 | INTRAVASCULAR ADMINISTRATION SET Custom Assemblies, Inc., Jan 4, 2000 |