The Recall Desk
CriticalFDA (Devices)·Z-2367-2015·Announced 2015-08-26

Teleflex Medical Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes

Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

Teleflex Medical is recalling the HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided) in sizes 28 Fr., 35 Fr., 37 Fr., 39 Fr., and 41 Fr. The recall involves 188,195 total units distributed worldwide, including the United States and several international markets.

The recall was initiated because the double swivel connector on the endobronchial tube may crack or separate. These devices are intended for use in thoracic surgery, bronchospirometry, and the administration of bronchial anesthesia.

The FDA has classified this recall as Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. Healthcare providers should stop using the affected devices and contact Teleflex Medical for further instructions.

The recalled product

Product
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring br
Manufacturer
Teleflex Medical
Category
Medical Device — Endobronchial Tubes
Hazard
Affected units
188,195

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 (20)

  • Product Code: 5-16028
  • Lot numbers: 01L1300279
  • 01A1400574
  • 73D1400255
  • 73F1400448
  • 73J1400537
  • 73A1500341 and 73C1500431
  • Product Code: 5-16035
  • Lot numbers: 01J1300471
  • 01J1300472
  • 01K1300050
  • 01K1300073
  • 01K1300578
  • 01L1300382
  • 01L1300383
  • 01L1300557
  • 01M1300073
  • 01M1300312
  • 01A1400226
  • 01A1400432

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

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Same hazard · structural failure

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