Teleflex recalls Iso-Gard Filter S with Expandi-Flex (REFs 19261 and 19272) due to incidents of device splitting or detaching during use. This microbial medical gas filter is for single-use in OUS only.
Incidents of device splitting or detaching during use
Teleflex is recalling certain Iso-Gard Filter S medical gas filters with Expandi-Flex that have been reported to split or detach during use. This could lead to potential safety issues for users in medical settings.
The filters can split or detach while in use, which may cause medical gas to be delivered improperly. This could lead to inadequate oxygen or other medical gases being administered to patients.
Healthcare facilities using these specific filters in oxygen therapy systems are most at risk. Patients receiving medical gas treatments through these filters may be affected.
Check for the model numbers 19261 or 19272 on the filter. These are single-use microbial medical gas filters sold only in the United States (OUS).
Identify the model number on the filter to confirm if it is 19261 or 19272.
Reach out to Teleflex for guidance on next steps if you have the recalled filters.
The recall is due to incidents of the device splitting or detaching during use, which could lead to improper medical gas delivery.
No, these specific models have been reported to split or detach during use, so they should not be used until the recall is resolved.
Look for model numbers 19261 or 19272 on the filter, which are single-use microbial medical gas filters sold only 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-0073-2023 — Teleflex Teleflex Hello, I own a Teleflex that is covered by recall Z-0073-2023 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.
