Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adju
FDA device recall Z-2687-2017 · posted 2017-07-06 · Terminated
Recall details
- Recalling firm
- Mallinckrodt Manufacturing LLC
- Reason for recall
- Product was improperly labeled leading to improper storage.
- Action taken
- 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
- Status
- Terminated
- Product code
- NBE
- Quantity affected
- 246 units
- Distribution
- Worldwide Distribution to the country : UK
- Date initiated
- 2014-10-17
- Date posted
- 2017-07-06
- Date terminated
- 2017-07-15
- Location
- Mountain View, CA
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