Device product
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Z-1823-2022
Product summary
- Event
- Event 90782
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,182 kits
- Official record key
device-enforcement:Z-1823-2022
Official wording
Reason: There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.
Code information: Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639
Distribution pattern: Domestic distribution to the following states: AL AZ CA CT DE FL GA HI IL KS MA MI MN MO NJ NY OH OR SC TX VA VT WA WI WV Foreign distribution to Barbados, Canada, Chile, Micronesia Federate, and Panama.
Derived failure modes
-
Sterility assurance
breach to the sterile barrier