Mallinckrodt Manufacturing LLC: Medical Device Recall in 2017 - (Recall #: Z-2687-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 17, 2014

Date Posted: July 12, 2017

Recall Number: Z-2687-2017

Event ID: 77482

Reason for Recall:

Product was improperly labeled leading to improper storage.

Status: Terminated

Product Quantity: 246 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution to the country : UK

Voluntary or Mandated:

Voluntary: Firm initiated