Home / Recalls / Circulatory Technology Inc / Z-2050-2016

Z-2050-2016 Class II Terminated

Recalled by Circulatory Technology Inc — Oyster Bay, NY

Recall Details

Product Type
Devices
Report Date
July 6, 2016
Initiation Date
March 3, 2016
Termination Date
April 20, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
72 units

Product Description

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

Reason for Recall

The seal between the balloon and the housing may leak.

Distribution Pattern

US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA

Code Information

Lot # 014603 USE BY: 9/2018

Other recalls by Circulatory Technology Inc

  • Z-1862-2021 Class II — The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) card (April 27, 2021)
  • Z-0817-2018 Class II — Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, (September 22, 2017)
  • Z-1171-2018 Class II — **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary byp (September 22, 2017)
  • Z-0057-2017 Class III — The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure n (July 1, 2016)
  • Z-2832-2016 Class II — The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38- (July 1, 2016)