FDAJuly 25, 2016device
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, i...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated
What to do
FDA enforcement status: Terminated
Brands named
terumo cardiovascular systemsterumoterumo cardiovascular
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
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