Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling 1,040 Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. These devices are used for airway suctioning in adults.
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: This is an FDA Class I recall, which establishes a minimum severity of 4 per the rubric. No reported deaths, serious injuries, or hospitalizations are documented, preventing classification as Critical.
Plain-English summary
Avanos Medical, Inc. is recalling approximately 1,040 units of Ballard Closed Suction Catheters, Model 227-5, due to lack of sterility assurance. These devices are used for airway suctioning in adult patients.
The recalled devices were distributed worldwide, including throughout the United States and internationally to Canada, Mexico, South Korea, New Zealand, Germany, England, Slovenia, France, Austria, and other locations. The affected lot is identified by Serial Number 1555468.
Healthcare providers should contact Avanos Medical, Inc. regarding the recall for instructions on the appropriate next steps.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- lack-of-sterility
- infection-risk
Distribution
Distributed nationwide across the United States.
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