Agency classClass IIOur severity:High FDA (Devices)·Z-0246-2016·Announced 2015-11-18

Teleflex Medical Recalls Rusch Flexi-slip Tracheal Tube Stylets

Teleflex Medical is recalling Rusch Flexi-slip tracheal tube stylets because the plastic coating may split or break off.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (coating splitting/breaking) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Teleflex Medical is recalling 233,641 units of Rusch Flexi-slip tracheal tube Stylets, Size Ch 6, Sterile. The recall is due to reports that the plastic coating of the stylet may split and/or break off from the device.

The affected products are identified by Material #503700-000060 and include batch numbers 13IG21, 13LG06, 14AG04, 14FG06, 14GG01, 14LG06, 15AG28, 15CG24, and 15DG38. These units were distributed nationwide in the United States and internationally to numerous countries including Argentina, Austria, Belgium, Canada, France, and the United Kingdom.

Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected stylets. The source text does not provide specific instructions for disposal or return, so users should contact Teleflex Medical for further guidance.

The recalled product

Product: Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: structural-defect
foreign-object
Affected units: 233,641

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 (9)

Material #503700-000060
Batch numbers: 13IG21
13LG06
14AG04
14FG06
14GG01
14LG06
15AG28
15CG24 and 15DG38.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Teleflex Medical

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Same hazard · structural defect