Circulatory Technology Recalls Bigger-Better-Bladder 2 Devices Due to Seal Leak
Circulatory Technology Inc is recalling 20 units of the Bigger-Better-Bladder, TM 2 device 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 device used in extracorporeal circuits, which presents a risk of harm without reported injuries, fitting the 'High' severity criteria.
Plain-English summary
Circulatory Technology Inc is recalling 20 units of the Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing (ITEM BBB38-72). This medical device is used to isolate pressure transducers from blood contact during extracorporeal procedures and to provide compliance in the circuit.
The recall was initiated because the seal between the balloon and the housing may leak. The affected units are from Lot # 014648 with a use-by date of 09/01/2018.
The recalled devices were distributed in the United States to the states of Louisiana, Michigan, New York, Ohio, Oregon, and Texas. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal…
- Manufacturer
- Circulatory Technology Inc
- Hazard
- Affected units
- 20
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 # 014648 USE BY: 09/01/2018
Distribution
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