Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (model 2271418-5) with lot code 1555430 due to lack of sterility assurance. 1,420 units were distributed 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 Class I classification applies; lack of sterility assurance in closed suction catheters poses significant risk of serious infection in patients. Class I medical device recalls represent the highest regulatory severity category.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters (model 2271418-5) for adults. The recall affects 1,420 units with lot code 1555430.
The catheters are being recalled due to lack of sterility assurance. Sterile medical devices are essential for patient safety, and the absence of proper sterility safeguards in these catheters creates risk of serious infection.
The recalled product was distributed nationwide throughout the United States and internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.
Healthcare facilities and consumers in possession of the affected catheters should cease use and contact Avanos Medical for guidance on replacement or return procedures.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 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.
- Hazard
- lack-of-sterility
- infection-risk
Distribution
Distributed nationwide across the United States.
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