Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tenaxis Medical ArterX(TM) Surgical Sealant Recalled by Mallinckrodt Manufacturing LLC Due to Product was improperly labeled leading to improper storage.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mallinckrodt Manufacturing LLC directly.
Affected Products
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.
Quantity: 246 units
Why Was This Recalled?
Product was improperly labeled leading to improper storage.
Where Was This Sold?
Worldwide Distribution to the country : UK
About Mallinckrodt Manufacturing LLC
Mallinckrodt Manufacturing LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report