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Terminated

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.

FDA Recall Z-2687-2017 · Posted 2017-07-06

Recalling FirmMallinckrodt Manufacturing LLC
Recall StatusTerminated
Product CodeNBE
Date Initiated2014-10-17
Date Terminated2017-07-15
Product Quantity246 units

Reason for Recall

Product was improperly labeled leading to improper storage.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution to the country : UK

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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