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Recall Observatory FDA recall evidence

Device product

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.

Z-1822-2022

August 12, 2022

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 90782
Status
Ongoing
Classification
Class II
Quantity
5,182 kits
Official record key
device-enforcement:Z-1822-2022

Official wording

Reason: 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.

Code information: Lot 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

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach to the sterile barrier