Agency classClass IOur severity:Severe FDA (Devices)·Z-1761-2019·Announced 2019-06-26

Teleflex Recalls Hudson RCI Sheridan Endotracheal Tubes Due to Disconnection

Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan EZ-ENDO endotracheal tubes because the 15 mm Sheridan connector may disconnect from the 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 55,312 units of Hudson RCI Sheridan EZ-ENDO endotracheal tubes in six sizes (6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, and 8.5 mm). The recall covers specific product codes and lot numbers distributed worldwide and across the United States.

The recall is due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. The source text notes that 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 recall notice. If the affected products are found, they should be removed from use and returned to Teleflex Medical or the authorized distributor.

The recalled product

Product: Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product…
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: disconnection
airway-loss
Affected units: 55,312

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 (2)

1) EZ-ENDO 6.0 mm
Product Code 5-22517 Lot Numbers: 73J1600767 73C1800202

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 →

Same manufacturer · Teleflex Medical

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Same hazard · disconnection