FDA Enforcement
Class III
Terminated
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.
Recall: Z-0057-2017
·
Reported October 19, 2016
Enforcement
- Recall Number
- Z-0057-2017
- Event ID
- 74614
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Circulatory Technology Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 19, 2016
- Initiation Date
- July 1, 2016
- Classification Date
- October 7, 2016
- Termination Date
- April 14, 2017
- Address
- 21 Singworth St, N/A, Oyster Bay, NY, 11771-3703, United States
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
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Code Info
Lot Numbers: R19229, 015323, 014882, 014602 & 014601
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.
Quantity
958 units