Haylard Closed Suction System for Neonates/Pediatrics — Class II medical device recall Z-0788-2020
Terminated recall by Avanos Medical, Inc., reported 2020-01-15, distributed nationwide. Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Sucti
| Recall number | Z-0788-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2019-11-05 |
| Classified | 2020-01-08 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2023-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BR, CA, CH, CL, CZ, DE, DK, ES, FR, GB, GR, HN, HR, IE, IL, IN, IT, KR, LB, MX, NL, NO, NP, NZ, PE, PL, PT, SA, SE, SG, SI, SK, TR |
| Lot numbers | 20000095/2024JUL, M18044T405/2023-FEB, M18115T401/2023-APR, M18121T402/2023-MAY, M18128T404/2023-MAY, M18143T401/2023-MAY, M18143T403/2023-MAY, M18149T403/2023-MAY, M18156T402/2023-JUN, M18170T402/2023-JUN, M18177T402/2023-JUN, M18192T401/2023-JUL, M18192T402/2023-JUL, M18206T401/2023-JUL, M18220T402/2023-AUG, M18247T402/2023-SEP, M18254T404/2023-SEP, M18254T405/2023-SEP, M18274T401/2023-OCT, M18274T402/2023-OCT, M18282T404/2023-OCT, M18290T402/2023-OCT, M18296T405/2023-OCT, M18296T406/2023-OCT, M18311T401/2023-NOV, M18311T402/2023-NOV, M18311T403/2023-NOV, M18318T401/2023-NOV, M18318T402/2023-NOV, M18324T401/2023-NOV, M18324T402/2023-NOV, M18332T401/2023-NOV, M18339T401/2023-DEC, M18345T403/2023-DEC, M18345T404/2023-DEC, M1834T403/2023-DEC, M18352T402/2023-DEC, M18358T403/2023-DEC, M18358T404/2023-DEC, M19008T401/2024-JAN and 31 more |
| Model numbers | 195, 195-5, 201, 202 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0788-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.