Iso-Gard Filter S Recalled for Device Splitting or Detachment During Use

Plain-English summary

Teleflex LLC is recalling Iso-Gard Filter S microbial medical gas filters (reference numbers 19211 for outside-US distribution and 19212) due to incidents of device splitting or detaching during use. This single-use filter is designed to provide bacterial and viral protection in breathing systems. Approximately 60,500 units have been distributed throughout the United States.

When the filter splits or detaches during use, the device may fail to perform its intended protective function. Healthcare providers and patients using affected filters should discontinue use immediately and contact Teleflex or their medical device supplier for replacement or return instructions.

The FDA has classified this as a Class I recall. Consumers with questions may contact the FDA or Teleflex LLC for additional information regarding this recall.

The recalled product

Product

Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.

Manufacturer

TELEFLEX LLC

Category

Medical Device — Respiratory Filter / Microbial Protection

Hazard

• device-splitting
• device-detachment
• filter-failure
• pathogen-exposure-risk

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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