FDA
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 was improperly labeled leading to improper storage.
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.