Teleflex is recalling Iso-Gard Filter S models 19211 and 19212 for potential splitting or detaching during use, which could compromise medical gas filtration. Affected units sold in the U.S. only.
Incidents of device splitting or detaching during use
Teleflex is recalling certain Iso-Gard Filter S medical gas filters (models 19211 and 19212) because they can split or detach during use. This could lead to bacterial or viral contamination of medical gas systems. The recall applies only to units sold in the U.S.
The filters can split or detach while in use, potentially allowing bacteria or viruses to enter the medical gas system. This could compromise patient safety during breathing treatments.
Healthcare facilities using these filters for medical gas systems in the U.S. are most at risk. Patients and staff could be exposed to bacteria or viruses if the filter fails during use.
Check if your filter has model numbers 19211 or 19212. These are single-use medical filters sold in the U.S. only. The product codes include specific UDI (Unique Device Identification) numbers listed in the recall.
Look for model numbers 19211 or 19212 on the filter's label or packaging.
Reach out to Teleflex directly for assistance with the recall or to confirm if your filter is affected.
Yes, these filters are single-use medical gas filters used in healthcare settings for patient breathing systems.
The recall requires checking if your filter is affected. If it is, you should contact Teleflex for instructions on replacement or disposal.
If the filter splits or detaches during use, it could allow bacteria or viruses to enter the medical gas system, potentially exposing patients to infection.
We’ve drafted a message you can send Teleflex to request your refund or repair — edit it as you like.
Subject: Recall Z-0072-2023 — Teleflex Teleflex Hello, I own a Teleflex that is covered by recall Z-0072-2023 from Teleflex. 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.
