PlainRecalls
FDA Devices Moderate Class II Terminated

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

Reported: July 6, 2016 Initiated: March 3, 2016 #Z-2050-2016

Product Description

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

Reason for Recall

The seal between the balloon and the housing may leak.

Details

Units Affected
72 units
Distribution
US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
Location
Oyster Bay, NY

Frequently Asked Questions

What product was recalled?
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38. Recalled by Circulatory Technology Inc. Units affected: 72 units.
Why was this product recalled?
The seal between the balloon and the housing may leak.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2050-2016.