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Recall Observatory FDA recall evidence

Device product

Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.

Z-1847-2016

March 03, 2016

Class II

Product summary

Firm
Covidien LLC
Event
Event 73427
Status
Terminated
Classification
Class II
Quantity
713600
Official record key
device-enforcement:Z-1847-2016

Official wording

Reason: Compromised sterility due to breach of barrier

Code information: All lots beginning with 110000037462 through Lot 120002259962

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