Recall Z-1823-2022 ยท MQG Accessory, Assisted Reproduction
CooperSurgical, Inc.
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
| Date | Sep 28, 2022 (initiated Aug 12, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On August 12, 2022, the firm notified customers via an Urgent Medical Device Safety Notice. Customers were instructed to quarantine affected product in their inventory. Once customers complete and return the Acknowledgement and Receipt Form attached to the recall letter, the firm will arrange for the affected product to be returned at no cost. Customers will receive credit for returned affected product. CooperSurgical may be reached at 203-601-5200 ext. 03300 or recall@coopersurgical.com. |
| Quantity | 5,182 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121566 | PLANER BT37 INCUBATOR Planer Plc, Nov 29, 2012 |