FDAClass IIJuly 6, 2016

Bigger-Better-Bladder With 3/8" ID tubing recall

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

Why was Bigger-Better-Bladder With 3/8" ID tubing recalled?

The seal between the balloon and the housing may leak.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 014603 USE BY: 9/2018

Product
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Recalling firm
Circulatory Technology Inc
Quantity
72 units
Distribution
US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
Recall date
July 6, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls