Recall Z-2050-2016— Circulatory Technology Inc

Name: FDA recall Z-2050-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-03

Class II · Terminated

Class II FDA medical device recall by Circulatory Technology Inc, initiated 2016-03-03, terminated 2017-04-20. It names one FDA 510(k) clearance: K981284. Product: Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38. Reason: The seal between the balloon and the housing may leak..

Recalling firm: Circulatory Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-03
Terminated: 2017-04-20
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

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

Reason for recall

The seal between the balloon and the housing may leak.

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