Z-2687-2017Class II

Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC...

Name: Z-2687-2017 Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC...
Creator: Mallinckrodt Manufacturing LLC
Published: 2014-10-17
License: https://open.fda.gov/license/

Mallinckrodt Manufacturing LLC / initiated 2014-10-17 / Terminated / root cause: labeling and UDI

FDA source

Mallinckrodt Manufacturing LLC began a recall of 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 on 2014-10-17. FDA classified it as Class II and gives the reason as "Product was improperly labeled leading to improper storage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2687-2017
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Posted: 2017-07-06
Terminated: 2017-07-15
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.
Product code: NBE Sealant, Polymerizing
Reason for recall: Product was improperly labeled leading to improper storage.
Root cause tag: labeling and UDI
FDA 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 in commerce: 246 units
Distribution: Worldwide Distribution to the country : UK
Product codes and lots: Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2687-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2687-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-06

Product code NBE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)