Device product
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.
Z-0057-2017
Product summary
- Event
- Event 74614
- Status
- Terminated
- Classification
- Class III
- Quantity
- 958 units
- Official record key
device-enforcement:Z-0057-2017
Official wording
Reason: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Code information: Lot Numbers: R19229, 015323, 014882, 014602 & 014601
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.
Derived failure modes
-
Unknown
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.