Avanos Recalls Haylard Closed Suction Systems Due to Blocked Lumens
Avanos Medical is recalling Haylard Closed Suction Systems for neonates and pediatrics because the central lumen may be blocked, potentially preventing adequate suctioning of airway secretions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device failure that could lead to oxygen desaturation in vulnerable neonatal and pediatric patients, representing a risk of harm where specific injury reports are not detailed in the provided text.
Plain-English summary
Avanos Medical, Inc. is recalling specific lots of the Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr. The recall involves four reference numbers: REF 195, REF 201, REF 202, and REF 195-5. A total of 114,300 units were distributed, with 37,880 units in the United States and 76,420 units distributed internationally to numerous countries including Canada, the United Kingdom, and Germany.
The recall was initiated after reports indicated that the central lumen of some of these 5 Fr catheters may be fully or partially blocked. This defect may cause the closed suction catheters to inadequately suction secretions and/or saline fluids from the patient's airway, which is necessary to prevent oxygen desaturation.
Healthcare facilities and distributors should identify the affected units by checking the specific lot codes and expiration dates listed in the official recall notice. Patients and caregivers should contact their healthcare provider or the manufacturer for instructions on how to proceed with the affected devices.
The recalled product
- 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
- Manufacturer
- Avanos Medical, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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