Z-0400-2022 Class II Terminated
FDA device recall Z-0400-2022 was initiated by Stradis Medical, LLC dba Stradis Healthcare on October 28, 2021 and is designated Class II. 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 … The recall status is terminated (terminated August 7, 2023). Affected quantity: 620 tube sets.
Recall Details
- Product Type
- Devices
- Report Date
- December 29, 2021
- Initiation Date
- October 28, 2021
- Termination Date
- August 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 620 tube sets
Product Description
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
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 Pattern
NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
Code Information
Lot code 20519-2103