Cook Medical recalls Disposable Humidification Flasks (Reference Part Number K-MINC-CTS-S) due to a manufacturing defect that may cause silicone stoppers to dislodge or gas leaks, impairing incubator function.
A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.
Cook Medical is recalling certain Disposable Humidification Flasks that may have a manufacturing defect causing silicone stoppers to dislodge or gas leaks. This could impair the incubator's ability to deliver proper gas flow to the baby's breathing system.
A small percentage of these flasks have a manufacturing defect that can cause silicone stoppers to dislodge or gas to leak. This may impair gas flow to the incubator's breathing chamber, potentially affecting the baby's oxygen levels.
Parents or caregivers using the Mini Incubator with the recalled flasks are most at risk. The flasks are used in medical settings for neonatal care.
Check for the Reference Part Number K-MINC-CTS-S and Lot Numbers listed in the recall (e.g., A1007159, A1007162, etc.). These flasks were sold with specific order numbers and lot numbers.
Look for the Reference Part Number K-MINC-CTS-S and Lot Numbers listed in the recall (e.g., A1007159, A1007162, etc.).
A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause silicone stoppers to dislodge or gas to leak, impairing gas flow to the incubator.
Check if your flask has the Reference Part Number K-MINC-CTS-S and Lot Numbers listed in the recall. If it does, stop using it and contact Cook Medical for further instructions.
The defect may cause gas leaks that impair gas flow to the incubator, potentially affecting the baby's oxygen levels. However, the recall states this is a small percentage of units and does not indicate immediate injury risk.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0809-2021 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0809-2021 from Cook Medical. 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.
