Recall Z-1862-2021— Circulatory Technology Inc.

Name: FDA recall Z-1862-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-27

Class II · Ongoing

Class II FDA medical device recall by Circulatory Technology Inc., initiated 2021-04-27. It names one FDA 510(k) clearance: K981284. Product: The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14. Reason: 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..

Recalling firm: Circulatory Technology Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-04-27
Firm location: Oyster Bay, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K981284 — BETTER-BLADDER (BB)Circulatory Technology, Inc.·cleared 1998-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.