Reported Dec 29, 2021 · Terminated
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Stradis Medical, LLC dba Stradis Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stradis Medical, LLC dba Stradis Healthcare · 3025 Northwoods Pkwy · Peachtree Corners, GA · 30071-1524
Is this the product you have?
- Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
- Lot codes and dates
- Lot code 20519-2103
- Amount recalled
- 620 tube sets
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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