Home / Recalls / Mallinckrodt Manufacturing LLC / Z-2687-2017

Z-2687-2017 Class II Terminated

Recalled by Mallinckrodt Manufacturing LLC — Mountain View, CA

Recall Details

Product Type: Devices
Report Date: July 12, 2017
Initiation Date: October 17, 2014
Termination Date: July 15, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 246 units

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.

Distribution Pattern

Worldwide Distribution to the country : UK

Code Information

Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001