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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 II Benchtop Incubator (AY200246)

Z-1823-2022

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-1823-2022

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 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639

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