Avanos Medical, Inc. recalls Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303…

Recall date

November 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0788-2020

FDA classification

Class II

Brand / firm

Avanos Medical, Inc.

Sold / distributed

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, Mexico, Nepal, Netherlands, New Zealand, Norway, Peru, Poland,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5 Y-Adapter, SAP Finished Product Code 109838302.