The Better-Bladder With 14" ID tubing recall
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the…
Why was The Better-Bladder With 14" ID tubing recalled?
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
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 Numbers: R19229, 015323, 014882, 014602 & 014601
- Product
- The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the…
- Recalling firm
- Circulatory Technology Inc
- Quantity
- 958 units
- Distribution
- US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
- Recall date
- October 19, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)