Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Reported: December 29, 2021 Initiated: October 28, 2021 #Z-0400-2022
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.
Details
- Recalling Firm
- Stradis Medical, LLC dba Stradis Healthcare
- Units Affected
- 620 tube sets
- Distribution
- NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
- Location
- Peachtree Corners, GA
Frequently Asked Questions
What product was recalled? ▼
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk. Recalled by Stradis Medical, LLC dba Stradis Healthcare. Units affected: 620 tube sets.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 29, 2021. Severity: Moderate. Recall number: Z-0400-2022.
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