The Recall Desk
HighFDA (Devices)·Z-1428-2018·Announced 2018-04-25

Halyard Closed Suction System Flex Connectors May Disconnect During Use

Halyard Health is recalling certain Closed Suction Systems because Flex Connectors may become loose or disconnect before or during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a medical device used for airway management where disconnection poses a risk of harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Halyard Health, Inc. is recalling certain Halyard Closed Suction Systems for Adults, including Turbo-Cleaning and Trach Care-72 models with Double Swivel Elbow (DSE) configurations. The recall involves 32,189 cases, totaling 643,780 units, which were distributed worldwide, including nationwide in the United States and Puerto Rico.

The recall is being issued because certain Flex Connectors supplied with these kits may become loose or disconnect before use or during use. These systems are used to aspirate liquids or semisolids from a patient's upper airway.

Halyard Health is the recalling firm. The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop use or contact the manufacturer, nor does it report any specific injuries or illnesses associated with the defect.

The recalled product

Product
Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-7
Manufacturer
Halyard Health, Inc
Category
Medical Device — Respiratory / Suction
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 (20)

  • Product Description
  • Product code: a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN)
  • 227
  • b. HALYARD* TRACH CARE-72 DSE ENDO 14FR
  • 227-5
  • c. HALYARD* TRACH CARE-72 WET PAK* 14FR
  • 22701356-5
  • d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR
  • 2270156-5
  • e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN)
  • 22703
  • f. HALYARD* TRACH CARE-72 DSE TRACH 14FR
  • 22703-5
  • g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR
  • 227036-5
  • h. HALYARD* TRACH CARE-72 DSE ENDO 10FR
  • 227101-5
  • i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK)
  • 2271013
  • j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Halyard Health, Inc 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 3 products in this recall →

Related recalls

Same manufacturer · Halyard Health, Inc

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Same hazard · disconnection

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