Ballard Closed Suction Catheters recalled due to sterility assurance failure
Avanos Medical recalls 1980 units of Ballard Closed Suction Catheters due to lack of sterility assurance. These neonatal and pediatric medical devices were distributed nationwide and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. Lack of sterility assurance in medical devices used for airway management in vulnerable neonatal and pediatric populations poses significant infection risk.
Plain-English summary
Avanos Medical, Inc. is recalling 1980 units of Ballard Closed Suction Catheters, Model 198 (8F Y-Adapter). These devices are used for suctioning in neonatal and pediatric patients.
The recall was initiated due to lack of sterility assurance in the closed suction catheter systems. Non-sterile medical devices pose a significant infection risk, especially for vulnerable populations such as neonates and pediatric patients.
The affected devices (lot/serial number 1561168) were distributed both domestically throughout the United States and internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- sterility-failure
- infection-risk
Distribution
Distributed nationwide across the United States.
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