Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0788-2020 — 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 Finis

U.S. FDA — Device Enforcement · United States · 2019-11-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0788-2020
Date of alert: 2019-11-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Avanos Medical, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 20000095

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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