Z-0057-2017 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2016
- Initiation Date
- July 1, 2016
- Termination Date
- April 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 958 units
Product Description
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Reason for Recall
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Distribution Pattern
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.
Code Information
Lot Numbers: R19229, 015323, 014882, 014602 & 014601