Recall Z-2687-2017 ยท NBE Sealant, Polymerizing
Mallinckrodt Manufacturing LLC
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.
| Date | Jul 6, 2017 (initiated Oct 17, 2014) |
| Status | Terminated |
| Reason | Product was improperly labeled leading to improper storage. |
| Root cause | Other |
| Action | The direct consignee was notified by email on October 17, 2014. The action requested to be taken on receipt of the notice: " Remove all ArterX delivered by CJ Medical from inventory and quarantine for return to CJ Medical. " Return the product to CJ Medical for a credit or product replacement " If no ArterX is found in inventory, please comment to that effect on the attached form and return the form to CJ Medical. The consignee was also requested to circulate the Field Safety Notice among all users affected by this product. For further questions, please call (314) 654-2000. |
| Quantity | 246 units |
| Distribution | Worldwide Distribution to the country : UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.