FDAFDA · Food and drugs·Recall number Z-2687-2017
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.
Published July 12, 2017 · Recall initiated: October 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product was improperly labeled leading to improper storage.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mallinckrodt Manufacturing LLC
- Distributor
- Worldwide Distribution to the country : UK
- Lot
- Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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