Use caution Medical device recall · FDA · Published November 5, 2019

Haylard Closed Suction System for Neonates/Pediatrics: Risk of blocked catheters causing

Avanos Medical recalls Haylard Closed Suction Systems for neonates/pediatrics with potential blocked catheters that may cause inadequate suction and oxygen desaturation. Affected units include specific model numbers and lot codes from 2022-2024.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0788-2020Medical device Avanos Medical ›

Use caution until it’s fixed

Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form the patient's airway to prevent oxygen desaturation.

Take action

Contact the company

Recalling firmAvanos Medical, Inc.5405 Windward Pkwy · Alpharetta, GA 30004-3894

✎ GovInfoNow plain-language explainer

Avanos Medical is recalling Haylard Closed Suction Systems for neonates and pediatrics due to a risk that the catheters may become blocked, which could lead to inadequate suction of airway secretions and oxygen desaturation. This is serious for infants and children who require these devices. Read more at govinfonow.com/recall/66562-haylard-closed-suction-system-for-neonates-pediatrics-risk-of-blocked.

Source Summary by GovInfoNow · govinfonow.com/recall/66562-haylard-closed-suction-system-for-neonates-pediatrics-risk-of-blocked · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0788-2020

Cite this page

“Haylard Closed Suction System for Neonates/Pediatrics: Risk of blocked catheters causing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66562-haylard-closed-suction-system-for-neonates-pediatrics-risk-of-blocked. Based on FDA recall #Z-0788-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0788-2020%22&limit=1).

The FDA announced on Nov. 5, 2019, that Avanos Medical, Inc. is recalling Haylard Closed Suction Systems for neonates and pediatrics due to potential lumen blockage. The agency said the defect may cause inadequate suctioning of secretions from a patient's airway.

How to tell if you have it

Brand: Avanos Medical
Product: Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr
REF 195, Y-Adapter, SAP Finished Product Code 109382303; Lot Codes M18115T401/2023-APR through M19134T404/2024-MAY
REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; Lot Codes M18044T405/2023-FEB through M7172T402/2022-JUN
REF 202, Elbow, SAP Finished Product Code 109382903; Lot Codes M18143T403/2023-MAY through M7346T403/2022-DEC
REF 195-5 Y-Adapter, SAP Finished Product Code 109838302; Lot Codes 20000095/2024-JUL through M19184T401/2024-JUL
Units affected: 114,300 (37,880 in the U.S., 76,420 outside the U.S.)

The hazard

Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters to inadequately suction secretions and/or saline fluids from the patient's airway to prevent oxygen desaturation.

Context

GovInfoNow's records show Avanos Medical, Inc. has 18 other recalls on record since Oct. 8, 2019. Other recent recalls of similar products include Medline Intubation Tray Recall (Dec. 24, 2025), Medline 14 Fr Suction Catheter Kits Recall (Dec. 24, 2025), and CooperSurgical Neonatal CPAP Replacement Set (Aug. 11, 2026).

How to tell if you have this one

Check for the product name 'Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr' with specific model numbers: REF 195, REF 201, REF 202, or REF 195-5 Y-Adapter. Look for lot codes and expiration dates listed in the recall notice.

Brand
Avanos Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product model and lot code by checking the packaging or label for the specific reference numbers and expiration dates listed in the recall notice.
Contact Manufacturer
Reach out to Avanos Medical directly for assistance with the recall process or to confirm if your unit is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide. Internationally distributed to: Argentina, Australia, Austria, Brazil, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Honduras, India, Ireland, Israel, Italy, Korea, Republic of, Lebanon,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

Nov 5, 2019Firm started the recall
Jan 8, 2020FDA classified it Class II
Jan 15, 2020Published in FDA’s Enforcement Report
Aug 16, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/66562-haylard-closed-suction-system-for-neonates-pediatrics-risk-of-blocked">Haylard Closed Suction System for Neonates/Pediatrics: Risk of blocked catheters causing (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0788-2020 (November 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0788-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.