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Mallinckrodt Manufacturing LLC recalls Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC A
Recalled July 12, 2017 · FDA recall Z-2687-2017 · Mallinckrodt Manufacturing
Hazard
Product was improperly labeled leading to improper storage. · FDA Class II
Units
246 units
Sold at
Worldwide Distribution to the country : UK
Description
Product was improperly labeled leading to improper storage.
Product
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.
Manufacturer(s)
Mallinckrodt Manufacturing LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →