The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Teleflex Medical

See all →

Same hazard · structural defect

See all →