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.
FDA Recall Z-0788-2020 · Posted None
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Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodeBSY
Date Initiated2019-11-05
Date Terminated2023-08-16
Product Quantity114,300 units (37,880 US, 76,420 OUS)
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.
Firm 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 [email protected]. Questions from outside the US can be sent to [email protected].
Root Cause
Manufacturing material removal
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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