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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Avanos Medical, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Avanos Medical, Inc. is recalling Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished P due to Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or par. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026