Reported Jul 12, 2017 · Terminated
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC…
Mallinckrodt Manufacturing LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mallinckrodt Manufacturing LLC · 835 Maude Ave · Mountain View, CA · 94043-4021
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers
(a) 21130000120928001303080013032900130920013111300140108002401290014022600140430001 (b) 40611001
- Lot Numbers
- Amount recalled
- 246 units
Why it was recalled
Product was improperly labeled leading to improper storage.
This product could cause temporary or reversible health problems — stop using it.
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