Device product
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
Z-1851-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28085
- Official record key
device-enforcement:Z-1851-2016
Official wording
Reason: Compromised sterility due to breach of barrier
Code information: All lots beginning with 110000311262 through lot 15G162262X
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