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Recall Observatory FDA recall evidence

Device product

Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319

Z-1858-2016

March 03, 2016

Class II

Product summary

Firm
Covidien LLC
Event
Event 73427
Status
Terminated
Classification
Class II
Quantity
372480
Official record key
device-enforcement:Z-1858-2016

Official wording

Reason: Compromised sterility due to breach of barrier

Code information: All lots beginning with 100000010062 through lot 15J162962X

Distribution pattern: Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Compromised sterility