Ballard Closed Suction Catheters recalled for sterility assurance failure
Avanos Medical is recalling 2080 units of Ballard Closed Suction Catheters (Model 2210-5) due to lack of sterility assurance, an FDA Class I recall affecting users worldwide.
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 classified this as a Class I recall. Although no deaths, serious injuries, or reported illnesses are mentioned in the source, FDA Class I designation indicates a reasonable probability that use of the recalled device could cause serious adverse health consequences, warranting a Severe rating.
Plain-English summary
Avanos Medical, Inc. is recalling 2080 units of Ballard Closed Suction Catheters (Model 2210-5), a device used for airway suctioning in adults. The recall was initiated due to lack of sterility assurance in the recalled units.
The recalled devices were distributed nationwide throughout the United States, as well as internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara. The affected lot includes units with Lot/Serial Number 1555424.
Closed suction catheters are critical medical devices used in healthcare settings. Lack of sterility assurance can pose a risk of infection to patients who use these devices. Healthcare providers who have received these products should stop using them and contact Avanos Medical for instructions on device return or replacement.
Patients or healthcare providers with questions about this recall should contact Avanos Medical or consult with their healthcare provider for guidance on alternative products.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE 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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