The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1762-2019·Announced 2019-06-26

Teleflex Medical Recalls Hudson RCI Sheridan Tracheal Tubes Due to Disconnection Risk

Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the endotracheal tube.

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: "This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal…"

Plain-English summary

Teleflex Medical is voluntarily recalling 186,592 units of Hudson RCI Sheridan tracheal tubes. The affected products include preformed sizes ranging from 6.0 mm to 8.5 mm, distributed worldwide and nationwide in the US.

The recall is due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. These complaints represent less than 0.0025% of all in-scope distributed product.

Healthcare providers and facilities should check their inventory for the specific product codes and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Teleflex Medical according to their instructions.

The recalled product

Product
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314…
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard
Affected units
186,592

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)

  • Hudson RCI Sheridan: 1) Preformed 6.0 mm
  • Product Codes: a) 5-22212
  • Product Codes: a) 5-22313
  • Lot Numbers: 73A1700274 73H1700612 73J1700474 d) 5-22113
  • Lot Numbers: 73G1700427 73E1800394 3) Preformed 7.0 mm
  • Product Codes: a) 5-22214
  • Lot Numbers: 73F1700399 73K1800734 4) Preformed 7.5 mm
  • Product Codes: a) 5-22215
  • Product Codes: a) 5-22216

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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