Medical Gas Filter Devices Recalled Due to Splitting and Detachment Risk

Plain-English summary

Teleflex LLC is recalling certain batches of the Iso-Gard Filter S, a single-use microbial medical gas filter with a tethered cap. The device is used to filter medical gases in clinical settings.

The FDA has classified this as a Class I recall because the device may split or detach during use. This failure could compromise the integrity of the gas delivery system and potentially affect patient safety.

The recall applies to model references 19211T and 19212T with specific lot codes distributed throughout the United States. Healthcare facilities and medical professionals who have received these devices should identify and remove them from service.

If you have received one of these devices, contact Teleflex LLC or your medical device supplier for instructions on replacement and proper handling of the recalled filters.

The recalled product

Product

Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use

Manufacturer

TELEFLEX LLC

Category

Medical Device — Gas Delivery / Filtration Equipment

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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