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CooperSurgical, Inc. Recall 90782

Description: 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.

CooperSurgical, Inc. Recall 90782 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1822-2022
Event ID90782
Event DescriptionHumidifier 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.
Product TypeDevices
DistributionDomestic 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.
Quantity5,182 kits
Recall ReasonThere 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.
Device Classification20221005
Device Code InfoLot Numbers 05593V291121 18-1192 1812-68 18-1268 G000575 G003811 G003893 G004517 G004874 G005109 G005476 G005723 E160415 Expiration date range: 27 Jun 2022 to 07 Dec 2024
Center Classification Date20220928
Recall Initiation Date20220812
Recalling FirmCooperSurgical, Inc.
Initial Notification Letter
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