Ballard Closed Suction Catheters recalled due to lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters due to lack of sterility assurance, which poses a serious infection risk.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I medical device recall. The FDA's Class I classification indicates serious adverse health consequences or death are possible, which meets the critical severity threshold per the rubric.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters (Model 22714183-5, Lot Code 1555426) due to lack of sterility assurance in the closed suction catheter systems.
These catheters were distributed nationwide across multiple U.S. states and internationally to Canada, Mexico, South Korea, New Zealand, Germany, England, France, Austria, Slovenia, and Guadalajara.
The FDA has classified this as a Class I recall, indicating a serious potential for adverse health consequences.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Category
- Medical Device
- Hazard
- sterility-failure
- infection-risk
Distribution
Distributed nationwide across the United States.
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