Device product
Laparoscopy CDS
Z-2978-2018
Product summary
- Event
- Event 78411
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 kits
- Official record key
device-enforcement:Z-2978-2018
Official wording
Reason: One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.
Code information: Model: CDS920114F. Lot: 17MB5499
Distribution pattern: CA, NM
Derived failure modes
-
Sterility assurance
non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile