Home / Recalls / Circulatory Technology Inc. / Z-1862-2021

Z-1862-2021 Class II Ongoing

Recalled by Circulatory Technology Inc. — Oyster Bay, NY

Recall Details

Product Type
Devices
Report Date
June 23, 2021
Initiation Date
April 27, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
147 units

Product Description

The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

Reason for Recall

The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.

Distribution Pattern

US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.

Code Information

Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021

Other recalls by Circulatory Technology Inc.

  • 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)
  • Z-2050-2016 Class II — Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 (March 3, 2016)