Device 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.
Z-2687-2017
Product summary
- Event
- Event 77482
- Status
- Terminated
- Classification
- Class II
- Quantity
- 246 units
- Official record key
device-enforcement:Z-2687-2017
Official wording
Reason: Product was improperly labeled leading to improper storage.
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
Derived failure modes
-
Unknown
Product was improperly labeled leading to improper storage.