Z-2687-2017 Class II Terminated
FDA device recall Z-2687-2017 was initiated by Mallinckrodt Manufacturing LLC on October 17, 2014 and is designated Class II. Reason for recall: Product was improperly labeled leading to improper storage. The recall status is terminated (terminated July 15, 2017). Affected quantity: 246 units.
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