The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2368-2015·Announced 2015-08-26

Teleflex Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes Due to Connector Cracking

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

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 double swivel connector may crack or separate on the endobronchial tube."

Plain-English summary

Teleflex Medical is recalling specific lots of the HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided). The affected sizes are 28 Fr., 35 Fr., 37 Fr., 39 Fr., and 41 Fr. These sterile, prescription-only devices are intended for use in thoracic surgery, bronchospirometry, and the administration of bronchial anesthesia.

The recall is being issued because the double swivel connector on the endobronchial tube may crack or separate. A total of 188,195 units are involved in this recall. The products were distributed nationwide in the United States and in the Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand, and Vietnam.

Healthcare providers and facilities should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement. Patients who have had these devices used should contact their healthcare provider if they have concerns.

The recalled product

Product
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right 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…
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: 5-16128
  • Lot numbers: 73L1400012
  • 73K1400582
  • 73L1400233 and 73A1500039
  • Product Code: 5-16135
  • Lot numbers: 73B1500259
  • 73B1500293
  • 73C1500401
  • 73C1500426
  • 01K1300470
  • 01B1400479
  • 73D1400498
  • 73F1400096
  • 73H1400443
  • 73J1400117
  • 73K1400583
  • 73L1400094
  • 73A1500205
  • 73A1500206 and 73B1500258
  • Product Code: 5-16137

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 →

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