Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF… recallZ-2687-2017 · Mallinckrodt Manufacturing LLC · initiated Oct 17, 2014
Class II Terminated All recalls posted in July 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mallinckrodt Manufacturing LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was improperly labeled leading to improper storage.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-2687-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 17, 2014
- Posted by the FDA
- Jul 6, 2017
- Recalling firm
- Mallinckrodt Manufacturing LLC
- Quantity
- 246 units
- Product code
- NBE
- FDA submissions
- P100030
- Distribution
- Worldwide Distribution to the country : UK
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001
Other devices under the same FDA submission
1 device cleared under P100030 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PREVELEAK SURGICAL SEALANT ADS201808Baxter Healthcare Corporation · Sealant, polymerizing1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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