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FDAAugust 12, 2022device

Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

coopersurgical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246) — Recall Details · AllClear