CooperSurgical, Inc. Recall 90782
Description: Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
CooperSurgical, Inc. Recall 90782 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1823-2022 |
| Event ID | 90782 |
| Event Description | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246) |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 5,182 kits |
| Recall 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. |
| Device Classification | 20221005 |
| Device Code Info | Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639 |
| Center Classification Date | 20220928 |
| Recall Initiation Date | 20220812 |
| Recalling Firm | CooperSurgical, Inc. |
| Initial Notification | Letter |
| Similar To |