Recall Z-2687-2017— Mallinckrodt Manufacturing LLC

Name: FDA recall Z-2687-2017
Creator: U.S. Food and Drug Administration
Published: 2014-10-17

Class II · Terminated

Class II FDA medical device recall by Mallinckrodt Manufacturing LLC, initiated 2014-10-17, terminated 2017-07-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Product was improperly labeled leading to improper storage..

Recalling firm: Mallinckrodt Manufacturing LLC
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Terminated: 2017-07-15
Firm location: Mountain View, CA, United States

Product description

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.

Reason for recall

Product was improperly labeled leading to improper storage.

Data sourced from openFDA. This site is unofficial and independent of the FDA.