Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 198, 8 F, Y-Adapter) for neonates and pediatrics due to lack of sterility assurance. The recall affects 1,980 units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I medical device recall. Per the severity rubric, FDA Class I recalls are never scored below 4, and given the critical nature of sterility assurance for invasive devices used in vulnerable neonatal and pediatric populations, a Severe rating is appropriate.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters, Model 198, 8 F, Y-Adapter, designed for use in neonates and pediatrics. The recall affects 1,980 units that were distributed worldwide, including throughout the United States and in Canada, Mexico, South Korea, New Zealand, Germany, England, Slovenia, France, Austria, and Guadalajara.
The recalled catheters lack sterility assurance. Lot Serial Number 1561168 is affected, with the following code identifiers: Each 00609038938264, DSP 10609038938261, and Case 20609038938268.
Patients or healthcare providers who have this product should stop using it and contact Avanos Medical, Inc. for instructions on return or replacement. Healthcare facilities should check their inventory for the affected lot and quarantine any units that match the recalled serial number.
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.
- Affected units
- 1,980
Distribution
Part of a larger recall action
This product is one of 8 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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