| Class 2 Device Recall Halyard Closed Suction System for Neonates/Pediatrics (5 Fr) | |
Date Initiated by Firm | November 05, 2019 |
Create Date | January 08, 2020 |
Recall Status1 |
Terminated 3 on August 16, 2023 |
Recall Number | Z-0788-2020 |
Recall Event ID |
84227 |
Product Classification |
Catheters, suction, tracheobronchial - Product Code BSY
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Avanos Medical, Inc. 5405 Windward Pkwy Alpharetta GA 30004-3894
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For Additional Information Contact | 470-448-5591 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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