Custom Assemblies recall: Sterility Concern
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Why was Custom Assemblies 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot code 20519-2103
- Product
- Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Quantity
- 620 tube sets
- Distribution
- NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
- Recall date
- December 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)