Ballard Closed Suction Catheters lack sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. The recall affects 1,040 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 classified this as a Class I recall. Per the severity rubric, FDA Class I recalls are never scored below 4, and this medical device recall involves loss of sterility assurance for a catheter—a direct-contact invasive device—which creates significant potential for infection.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Turbo-Cleaning Closed Suction System for Adults (Model 227-5, 14 F, DSE) due to a lack of sterility assurance. The recalled product includes 1,040 units identified by Lot/Serial Number 1555468.
The closed suction catheters were distributed worldwide, including throughout the United States (AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI) and internationally (South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara).
Patients and healthcare providers who have this product should contact Avanos Medical, Inc. for instructions on return or replacement. This is a Class I recall, indicating a serious health hazard.
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.
- Affected units
- 1,040
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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