Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubat...
FDA Recall #Z-1823-2022 — Class II — August 12, 2022
Product Description
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
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.
Recalling Firm
CooperSurgical, Inc. — Trumbull, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated