AllClear
PricingSign in
FDAOctober 28, 2021device

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Terminated

Brands named

stradis medical llc dba stradis healthcarestradisstradis medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →