The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0869-2015·Announced 2014-12-31

Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk

Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.

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 cuff inflation line may detach from the endotracheal tube during use."

Plain-English summary

Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes, 9.0 mm, distributed by Kimberly Clark Global Sales, LLC. The recall involves 80 cases (10 tubes per case) of the product, which is used for airway management by oral intubation of the trachea and for the removal of secretions that accumulate in the subglottic space.

The recall is being issued because the cuff inflation line may detach from the endotracheal tube during use. This defect could compromise the device's function during critical airway management procedures.

The affected product was distributed worldwide, including nationwide in the United States and in countries such as Australia, Canada, various European nations, Hong Kong, New Zealand, and the United Arab Emirates. Specific lot numbers involved include AA3274, AA3274V02, AA4062, AA4062V05, AA4092V02, AA4104V01, AA4111V03, AA4174V02, and AA4190V01. Healthcare facilities should stop using the affected lots and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Manufacturer
Halyard Health
Category
Medical Device — Endotracheal Tubes
Hazard

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)

  • Product Code: 13224
  • Lot numbers: AA3274
  • AA3274V02
  • AA4062
  • AA4062V05
  • AA4092V02
  • AA4104V01
  • AA4111V03
  • AA4174V02 & AA4190V01.

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Halyard Health 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 5 products in this recall →

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