CLASS II Device recall · Reported 12 Jul 2017 · FDA Enforcement Report
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) recalled
Mallinckrodt Manufacturing is recalling Tenaxis Medical ArterX(TM) Surgical Sealant, (a). The recall was initiated on 17 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2687-2017
- FDA event ID
- 77482
- Recalling firm
- Mallinckrodt Manufacturing, Mountain View, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2014
- FDA classified
- 6 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 17 Oct 2014 | Recall initiated by company | |
| 6 Jul 2017 | Classified by FDA | +993 days |
| 12 Jul 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was improperly labeled leading to improper storage.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution to the country : UK
Questions about this recall
Why was it recalled?
Product was improperly labeled leading to improper storage.
Which lots are affected?
Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001
Where was it sold?
Worldwide Distribution to the country : UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mallinckrodt Manufacturing
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|---|---|---|---|---|---|
| Device | CLASS I | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 recalled | Mallinckrodt Manufacturing | Other | WI |
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