FDAOctober 17, 2014device
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Product was improperly labeled leading to improper storage.
What to do
FDA enforcement status: Terminated
Brands named
mallinckrodt manufacturingmallinckrodt
Recall history
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