Reported Oct 5, 2022 · Ongoing
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark…
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers
05593V29112118-11921812-6818-1268G000575G003811G003893G004517G004874G005109G005476
- G005723 E160415 Expiration date range27 Jun 2022 to 07 Dec 2024
- Lot Numbers
- Amount recalled
- 5,182 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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