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Recall Observatory FDA recall evidence

Device product

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.

Z-2687-2017

October 17, 2014

Class II

Product summary

Firm
Mallinckrodt Manufacturing LLC
Event
Event 77482
Status
Terminated
Classification
Class II
Quantity
246 units
Official record key
device-enforcement:Z-2687-2017

Official wording

Reason: Product was improperly labeled leading to improper storage.

Code information: Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001

Distribution pattern: Worldwide Distribution to the country : UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was improperly labeled leading to improper storage.