Agency classClass IOur severity:Severe FDA (Devices)·Z-0044-2017·Announced 2016-10-26

Teleflex Medical Recalls Willy Rusch Tracheostomy Tube Sets

Teleflex Medical is recalling Willy Rusch Tracheostomy Tube Sets because the connector may disconnect from the tube during use.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The connector may disconnect from the tracheostomy tube during use."

Plain-English summary

Teleflex Medical is recalling Willy Rusch GmbH Tracheostomy Tube Sets. The recall involves 1,095 units distributed nationwide in the United States and in Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey. The affected lots are 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, and 15491.

The recall is being issued because the connector may disconnect from the tracheostomy tube during use. This product is used for the cannulation of tracheotomised patients, particularly in cases involving a narrow tracheostoma and narrow-lumen tracheas.

Healthcare providers and patients should stop using the affected tracheostomy tube sets and contact Teleflex Medical for further instructions.

The recalled product

Product: Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Manufacturer: Teleflex Medical
Category: Medical Device — Tracheostomy Tubes
Hazard: disconnection
Affected units: 1,095

Is your product affected?

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

Lot numbers (10)

Lot - 15451
15291
15331
15371
15501
15261
15391
15421
15461
15491

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Teleflex Medical

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Same hazard · disconnection