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Class 2 Device Recall Tenaxis Medical ArterX(TM) Surgical Sealant |
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Date Initiated by Firm |
October 17, 2014 |
Date Posted |
July 06, 2017 |
Recall Status1 |
Terminated 3 on July 15, 2017 |
Recall Number |
Z-2687-2017 |
Recall Event ID |
77482 |
PMA Number |
P100030 |
Product Classification |
Sealant,polymerizing - Product Code NBE
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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.
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Code Information |
Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001 |
Recalling Firm/ Manufacturer |
Mallinckrodt Manufacturing LLC 835 Maude Ave Mountain View CA 94043-4021
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Manufacturer Reason for Recall |
Product was improperly labeled leading to improper storage.
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FDA Determined Cause 2 |
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 in Commerce |
246 units |
Distribution |
Worldwide Distribution to the country : UK |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = NBE and Original Applicant = Baxter Healthcare Corporation
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