Stradis Medical, LLC dba Stradis Healthcare Recall 89046
Description: Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Stradis Medical, LLC dba Stradis Healthcare Recall 89046 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0400-2022 |
| Event ID | 89046 |
| Event Description | Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk |
| Product Type | Devices |
| Distribution | NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH |
| Quantity | 620 tube sets |
| Recall 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. |
| Device Classification | 20211229 |
| Device Code Info | Lot code 20519-2103 |
| Center Classification Date | 20211220 |
| Recall Initiation Date | 20211028 |
| Recalling Firm | Stradis Medical, LLC dba Stradis Healthcare |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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