Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
FDA Recall Z-1822-2022 · Posted 2022-09-28
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Recalling FirmCooperSurgical, Inc.
Recall StatusOpen, Classified
Product CodeMQG
Date Initiated2022-08-12
Product Quantity5,182 kits
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.
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 [email protected].
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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