Circulatory Technology Inc: Medical Device Recall in 2016 - (Recall #: Z-0057-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: July 1, 2016

Date Posted: October 19, 2016

Recall Number: Z-0057-2017

Event ID: 74614

Reason for Recall:

Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.

Status: Terminated

Product Quantity: 958 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated