FDA recall Z-1862-2021

Product

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

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

Key facts

Status

Ongoing

Initiation date

2021-04-27

Report date

2021-06-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oyster Bay, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1862-2021