Ballard Closed Suction Catheters recalled for sterility assurance failure
Avanos Medical is recalling 4,000 units of Ballard Closed Suction Catheters Model 210 used in neonatal and pediatric care due to lack of sterility assurance. The recall affects devices 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 medical device recall classification requires a minimum severity score of 4 (Severe) per the rubric. The lack of sterility assurance in devices used for neonatal and pediatric airway management presents risk of contamination and infection in vulnerable populations.
Plain-English summary
Ballard Closed Suction Catheters Model 210, manufactured by Avanos Medical, Inc., are medical devices used for suctioning secretions from airways in neonatal and pediatric patients. A total of 4,000 units with Lot Code 1561165 are included in this recall.
The devices are being recalled due to lack of sterility assurance. Sterility is critical for medical devices intended for respiratory use in vulnerable populations such as newborns and young children.
The affected devices have been distributed nationwide in the United States and internationally to multiple countries including Canada, Mexico, South Korea, New Zealand, and several European countries. Healthcare facilities that may have received these devices should review their inventory.
Healthcare providers should discontinue use of affected units immediately and contact Avanos Medical, Inc., for replacement or return instructions. Patients or families with concerns about device use should consult their healthcare provider.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- sterility-assurance
- contamination-risk
- infection-risk
Distribution
Distributed nationwide across the United States.
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