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.
This recall has been terminated (originally issued November 5, 2019).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- November 5, 2019
- Terminated
- August 16, 2023
- Recall Number
- Z-0788-2020
- Quantity
- 114,300 units (37,880 US, 76,420 OUS)
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
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.
Root Cause
Manufacturing material removal
Action Taken
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.