CooperSurgical recalls humidifier bottles and syringe filter kits for BT37 Mark I incubators due to potential sterile barrier breaches causing embryo contamination. Affected units include specific lot numbers and expiration dates.
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.
CooperSurgical is recalling humidifier bottles and syringe filter kits for their BT37 Mark I Benchtop Incubator. The recall is because the packaging might damage the sterile barrier, risking embryo contamination during incubation.
The packaging of the filter box inside the humidifier bottle could breach the sterile barrier. This might lead to using unsterilized devices, causing embryo contamination or loss during incubation.
Researchers and embryologists using the BT37 Mark I Benchtop Incubator with the affected humidifier bottles and filter kits. Those handling embryos are most at risk.
Check for lot numbers: 05593V291121, 18-1192, 1812-68, 18-1268, G000575, G003811, G003893, G004517, G004874, G005109, G005476, G005723, E160415. The product expires between June 27, 2022, and December 7, 2024.
Identify the lot numbers listed in the recall notice to confirm if your humidifier bottle or filter kit is affected.
The packaging of the filter box inside the humidifier bottle may breach the sterile barrier, risking embryo contamination during incubation.
Using the affected product could lead to contamination or loss of embryos due to a potential breach in the sterile barrier.
Check for lot numbers: 05593V291121, 18-1192, 1812-68, 18-1268, G000575, G003811, G003893, G004517, G004874, G005109, G005476, G005723, E160415. The product expires between June 27, 2022, and December 7, 2024.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1822-2022 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-1822-2022 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
