FDA-Device2017-07-12Class II
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.
Mallinckrodt Manufacturing LLC
Hazard
Product was improperly labeled leading to improper storage.
Sold states
Worldwide Distribution to the country : UK
Affected count
246 units
Manufactured in
835 Maude Ave, N/A, Mountain View, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2687-2017Don't want to check this manually?
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