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
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
Compromised sterility