Avanos Medical, Inc.: 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.

Recall number

Z-0788-2020

Recalling firm

Avanos Medical, Inc.

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.

Status

Terminated

Initiated

2019-11-05

Posted

not on file

Terminated

2023-08-16

Reason

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.

Root cause

Manufacturing material removal

Action

Consignees were sent an Urgent Product Advisory Notice letter beginning 11/05/2019 via email and overnight mail. The letter identified affected catalog codes, stated reason for recall, stated that blockage is detectable before catheter use by assessing suctioning effectiveness, and asked for a response form to be returned within 5 business days. questions in the US can be directed to avanos8446@stericycle.com. Questions from outside the US can be sent to avanos8446OUS@stericycle.com.

Quantity

114,300 units (37,880 US, 76,420 OUS)

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.

Lot, serial or model codes

REF 195 Lot Code / Expiration Date:  M18115T401/2023-APR, M18121T402/2023-MAY, M18128T404/2023-MAY, M18143T401/2023-MAY, M18149T403/2023-MAY, M18156T402/2023-JUN, M18170T402/2023-JUN, M18177T402/2023-JUN, M18192T402/2023-JUL, M18206T401/2023-JUL, M18220T402/2023-AUG, M18247T402/2023-SEP, M18254T405/2023-SEP, M18282T404/2023-OCT, M18311T401/2023-NOV, M18318T402/2023-NOV, M18345T403/2023-DEC, M1834T403/2023-DEC, M18358T403/2023-DEC, M19008T401/2024-JAN, M19058T402/2024-FEB, M19078T403/2024-MAR, M19086T401/2024-MAR, M19098T403/2024-APR, M19134T404/2024-MAY,   REF 201 Lot Code / Expiration Date:  M18044T405/2023-FEB, M18311T402/2023-NOV, M18358T404/2023-DEC, M19037T402/2024-FEB, M19065T402/2024-MAR, M7172T402/2022-JUN.   REF 202 Lot Code / Expiration Date:  M18143T403/2023-MAY, M18192T401/2023-JUL, M18254T404/2023-SEP, M18274T401/2023-OCT, M18296T405/2023-OCT, M18318T401/2023-NOV, M19072T401/2024-MAR, M19142T401/2024-MAY, M7346T403/2022-DEC.   REF 195-5 Lot Code / Expiration Date:  20000095/2024 - JUL, M18274T402/2023-OCT, M18290T402/2023-OCT, M18296T406/2023-OCT, M18311T403/2023-NOV, M18324T401/2023-NOV, M18324T402/2023-NOV, M18332T401/2023-NOV, M18339T401/2023-DEC, M18345T404/2023-DEC, M18352T402/2023-DEC, M19024T402/2024-JAN, M19030T401/2024-JAN, M19051T401/2024-FEB, M19059T401/2024-FEB, M19065T401/2024-MAR, M19072T402/2024-MAR, M19079T401/2024-MAR, M19085T402/2024-MAR, M19098T404/2024-APR, M19099T401/2024-APR, M19105T403/2024-APR, M19120T403/2024-APR, M19128T401/2024-MAY, M19128T403/2024-MAY, M19135T401/2024-MAY, M19142T402/2024-MAY, M19149T405/2024-MAY, M19162T403/2024-JUN, M19177T402/2024-MAY, M19184T401/2024-JUL.

510(k) numbers

not on file

PMA numbers

not on file

Product code

BSY

Firm FEI

3011270181

Firm city

Alpharetta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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