Recall Z-1171-2018— Circulatory Technology Inc

Name: FDA recall Z-1171-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-22

Class II · Terminated

Class II FDA medical device recall by Circulatory Technology Inc, initiated 2017-09-22, terminated 2020-05-20. It names one FDA 510(k) clearance: K981284. Product: **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers). 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: Terminated
Initiated: 2017-09-22
Terminated: 2020-05-20
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

**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)

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.