Ballard Closed Suction Catheters recalled due to sterility assurance failure
Avanos Medical is recalling 9,960 units of Ballard Closed Suction Catheters (Model 20083) used in neonatal and pediatric care due to lack of sterility assurance. Products may not be properly sterilized, creating infection risk.
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 requires a minimum severity score of 4 per the rubric. Although no reported illnesses or injuries are documented, the lack of sterility assurance in medical devices used for neonatal and pediatric airway care poses serious infection risk.
Plain-English summary
Avanos Medical, Inc. is recalling 9,960 units of Ballard Closed Suction Catheters, Model 20083, 8 F Elbow. The affected lot numbers are 1555215 and 1555217. The products have been distributed nationwide in the United States and internationally, including in South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.
The recall is due to lack of sterility assurance. These devices are closed suction catheters designed for use in neonatal and pediatric patient care. Sterility is essential for medical devices that contact patient airways and tissues.
Patients, families, and healthcare providers who have received or used these products should contact Avanos Medical, Inc. for further information regarding this recall.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- contamination-risk
- infection-risk
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 (2)
- Lot Code: Lot/ Serial Number(s): 1555215
- 1555217 Each: 00609038938311 DSP: 10609038938318 Case: 20609038938315
Distribution
Distributed nationwide across the United States.
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