The Recall Desk
HighFDA (Devices)·Z-1429-2018·Announced 2018-04-25

Halyard Closed Suction System Recall Due to Loose Flex Connectors

Halyard Health is recalling certain Closed Suction Systems because the 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 involves a medical device defect that poses a risk of harm to patients during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Halyard Health, Inc. is recalling certain Halyard Closed Suction Systems for Adults. These medical devices are used to aspirate liquids or semisolids from a patient's upper airway. The recall involves 32,189 cases, totaling 643,780 units, which were distributed worldwide, including the United States and numerous international locations.

The recall is being conducted because certain Flex Connectors supplied with the kits may become loose or disconnect before use or during use. This defect could compromise the integrity of the suction system during patient care.

Healthcare facilities and consumers should stop using the affected products and contact Halyard Health for further instructions on how to proceed with the recall.

The recalled product

Product
Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT,
Manufacturer
Halyard Health, Inc
Category
Medical Device — Respiratory Care
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* MULTI-PORT
  • DSY
  • ENDO 10FR
  • 24010-5
  • b. HALYARD* MULTI-PORT
  • ENDO 12FR
  • 240121-5
  • c. HALYARD* MULTI-PORT
  • ENDO
  • MDI 12FR
  • 240128-5
  • d. HALYARD* MULTI-PORT
  • ENDO 14FR
  • 24014-5
  • e. HALYARD* MULTI-PORT
  • TRACH 14FR
  • 240143-5
  • f. HALYARD* MULTI-PORT
  • TRACH

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

See all →

Same hazard · mechanical failure

See all →