The Recall Desk
HighFDA (Devices)·Z-1427-2018·Announced 2018-04-25

Halyard Closed Suction System Flex Connectors May Disconnect During Use

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 is classified as FDA Class II, and the hazard involves a medical device that may disconnect during use, posing a risk of harm to patients, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Halyard Health, Inc. is recalling certain Halyard Closed Suction Systems for Adults, Double Swivel Elbow (DSE). 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 markets.

The recall is being conducted because certain Flex Connectors supplied with the Halyard Closed Suction Kits may become loose or disconnect before use or during use. This defect could compromise the integrity of the suction system while it is being used on a patient.

Healthcare facilities and consumers should stop using the affected products immediately. Halyard Health is the recalling firm and is responsible for managing the recall process for these specific product codes and configurations.

The recalled product

Product
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12
Manufacturer
Halyard Health, Inc
Category
Medical Device — Suction Systems
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* 12FR DSE 21.3IN/54CM (WHITE)
  • (2160)
  • b. HALYARD* 12 FR TRACH CARE DSE ENDO
  • (2160-5)
  • c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE)
  • (21603)
  • d. HALYARD* 12FR TRACH CARE DSE TRACH
  • (21603-5)
  • e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN)
  • (22108130
  • 2210
  • 22106
  • 22107
  • 22108
  • 22108147
  • 8224)
  • f. HALYARD* 14FR TRACH CARE DSE ENDO
  • (2210-5)
  • g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN)

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 · device disconnection

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