Circulatory Technology Recalls Better-Bladder Devices Due to Cosmetic Defects
Circulatory Technology Inc is recalling 958 units of Better-Bladder devices with 14-inch tubing due to twisted or wrinkled balloon components.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly identifies the defect as a cosmetic issue, which aligns with the rubric's criteria for a Low severity score involving cosmetic defects.
Plain-English summary
Circulatory Technology Inc is recalling 958 units of the Better-Bladder With 14" ID tubing, ITEM BB14, STERILE. The recall is being conducted because the balloon components on these devices are twisted or wrinkled.
The affected devices are used to measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump. The recall covers specific lot numbers: R19229, 015323, 014882, 014602, and 014601.
The firm has classified the twisted or wrinkled balloon components as a cosmetic defect. The devices were distributed nationwide to facilities in Alabama, Arkansas, California, Washington, D.C., Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia.
The recalled product
- Product
- The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
- Manufacturer
- Circulatory Technology Inc
- Hazard
- Affected units
- 958
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: R19229
- 015323
- 014882
- 014602 & 014601
Distribution
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