Tenaxis Medical ArterX(TM) Surgical Sealant recall
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…
Why was Tenaxis Medical ArterX(TM) Surgical Sealant recalled?
Product was improperly labeled leading to improper storage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001
- 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…
- Recalling firm
- Mallinckrodt Manufacturing LLC
- Quantity
- 246 units
- Distribution
- Worldwide Distribution to the country : UK
- Recall date
- July 12, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)