Circulatory Technology Recalls Bigger-Better-Bladder Medical Devices Due to Seal Leak
Circulatory Technology Inc is recalling 72 units of Bigger-Better-Bladder devices because the seal between the balloon and housing may leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential leak in a medical device where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Circulatory Technology Inc is recalling 72 units of the Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38. The recall is due to a defect where the seal between the balloon and the housing may leak.
The affected products are identified by Lot # 014603 with a use-by date of 9/2018. These devices were distributed in the United States to the states of California, Indiana, Michigan, New York, Pennsylvania, Texas, and Virginia.
Consumers and healthcare providers should stop using the affected devices and contact Circulatory Technology Inc for further instructions.
The recalled product
- Product
- Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
- Manufacturer
- Circulatory Technology Inc
- Hazard
- Affected units
- 72
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 (1)
- Lot # 014603 USE BY: 9/2018
Distribution
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