Device product
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
Z-1855-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 350550
- Official record key
device-enforcement:Z-1855-2016
Official wording
Reason: Compromised sterility due to breach of barrier
Code information: All lots beginning with 110000476162 through lot 15J070162X
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