Teleflex Breathing Tubes Recalled Due to Reports of Tearing

Plain-English summary

Teleflex Medical Inc is recalling four models of corrugated breathing tubes following reports of torn tubes. The recalled products include the Flex tube (Product #20011, sterile), Smooth-Flo Flex with Double Swivel (Products #22511 sterile and #22512 non-sterile), and Smooth-Flo Flex (Product #22552, non-sterile), with approximately 290,809 units affected.

The recall was initiated following reports of torn corrugated breathing tubes. These structural defects in the tubing material represent a potential risk to proper device function.

The affected devices were distributed worldwide, including throughout the United States and to multiple international locations including Canada, Australia, and several European countries. Specific batch and UDI numbers for the recalled units are available from the FDA.

The recalled product

Product

(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.

Manufacturer

TELEFLEX MEDICAL INC

Category

Medical Device — Respiratory / Breathing Tubes

Hazard

• structural-defect
• torn-tubing

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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