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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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
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
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
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