FDA Medical Device Recalls (openFDA)
Mallinckrodt Manufacturing LLC: 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.
- Recall number
- Z-2687-2017
- Recalling firm
- Mallinckrodt Manufacturing LLC
- 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.
- Status
- Terminated
- Initiated
- 2014-10-17
- Posted
- 2017-07-06
- Terminated
- 2017-07-15
- Reason
- Product was improperly labeled leading to improper storage.
- Root cause
- 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
- 246 units
- Distribution
- Worldwide Distribution to the country : UK
- Lot, serial or model codes
- Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001
- 510(k) numbers
- not on file
- PMA numbers
- ["P100030"]
- Product code
- NBE
- Firm FEI
- 3006472186
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28