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.
Enforcement
- Recall Number
- Z-0788-2020
- Event ID
- 84227
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Avanos Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 15, 2020
- Initiation Date
- November 5, 2019
- Classification Date
- January 8, 2020
- Termination Date
- August 16, 2023
- Address
- 5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States
Description
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.
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.
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.
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.
114,300 units (37,880 US, 76,420 OUS)