The Bigger-Better-Bladder recall
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…
Why was The Bigger-Better-Bladder 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 # 014648 USE BY: 09/01/2018
- 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…
- Recalling firm
- Circulatory Technology Inc
- Quantity
- 20 units
- Distribution
- US Distribution to states of: LA, MI, NY, OH, OR & TX.
- Recall date
- September 21, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)