# FDA recall Z-0788-2020

> **Avanos Medical, Inc.** · Class II · device recall initiated 2019-11-05.

## Product

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.

## Reason for recall

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.

## 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, Mexico, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-0788-2020
- **Recalling firm:** Avanos Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-05
- **Report date:** 2020-01-15
- **Termination date:** 2023-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0788-2020

## Citation

> AI Analytics. FDA recall Z-0788-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0788-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*