Iso-Gard Filter S Medical Gas Filters Recalled Due to Device Splitting Risk

Plain-English summary

TELEFLEX LLC is recalling 355 units of the Iso-Gard Filter S medical gas filter with Expandi-Flex and Tethered Cap (model numbers 19261T, 19262T, and 19272T). This is a single-use microbial medical gas filter used in healthcare settings.

The recall addresses incidents in which the filter device splits or detaches during use. This device failure poses a serious risk during medical gas delivery applications.

The filters were distributed nationwide in the United States. Healthcare facilities and providers using this product should cease use, inspect affected units, and contact TELEFLEX LLC for guidance on replacement or return. Consumers can reference the specific model numbers, lot codes, and UDI information available from the FDA's recall database.

The recalled product

Product

Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,

Manufacturer

TELEFLEX LLC

Category

Medical Device — Respiratory Gas Filter

Hazard

• device-splitting
• device-detachment
• mechanical-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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