Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
- Company
- Coopersurgical, Inc.
- Recall Initiated
- August 12, 2022
- Posted
- September 28, 2022
- Recall Number
- Z-1823-2022
- Quantity
- 5,182 kits
- Firm Location
- Trumbull, CT
Reason for Recall
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.
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.
Lot / Code Info
Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639
Root Cause
Under Investigation by firm
Action Taken
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.