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 Adj…
- Recall date
- October 17, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2687-2017
- FDA classification
- Class II
- Brand / firm
- Mallinckrodt Manufacturing LLC
- Sold / distributed
- Worldwide Distribution to the country : UK
Why it was recalled
Product was improperly labeled leading to improper storage.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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