FDA-Device2022-10-05Class II
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
CooperSurgical, Inc.
Hazard
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.
Sold states
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.
Affected count
5,182 kits
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2022Don't want to check this manually?
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