Teleflex recalls Iso-Gard Filter S with Expandi-Flex/Elbow models REF 19012 and REF 19012T (OUS only) due to incidents of device splitting or detaching during use.
Incidents of device splitting or detaching during use
Teleflex is recalling two specific models of medical gas filters (Iso-Gard Filter S with Expandi-Flex/Elbow) that may split or detach during use. This could lead to potential safety issues for users in medical settings.
The filters may split or detach while in use, which could cause medical gas flow interruptions or other safety hazards. This is a risk during normal medical procedures but does not necessarily lead to immediate injury.
Medical professionals and patients using these filters in healthcare settings. Those with the specific model numbers listed in the recall are most at risk.
Check for the model numbers REF 19012 or REF 19012T with the unique identifiers (UDIs) listed in the recall. These filters are only sold in the United States (OUS).
Identify if your medical gas filter has the model numbers REF 19012 or REF 19012T with the specific unique identifiers listed in the recall.
Reach out to Teleflex directly for further assistance or to confirm if your specific model is affected.
The recall is due to incidents of the device splitting or detaching during use, which could cause medical gas flow interruptions.
The recall indicates a risk of splitting or detaching during use, so affected models should be checked for safety.
Check for the model numbers REF 19012 or REF 19012T with the specific unique identifiers listed in the recall. These filters are only sold in the United States.
We’ve drafted a message you can send Teleflex to request your refund or repair — edit it as you like.
Subject: Recall Z-0076-2023 — Teleflex Teleflex Hello, I own a Teleflex that is covered by recall Z-0076-2023 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.
