Recall Z-1708-2018— Datascope Corporation

Name: FDA recall Z-1708-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-19

Class II · Terminated

Class II FDA medical device recall by Datascope Corporation, initiated 2017-10-19, terminated 2020-04-24. It names one FDA 510(k) clearance: K080592. Product: Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504. Reason: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow..

Recalling firm: Datascope Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-10-19
Terminated: 2020-04-24
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K080592 — HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AG·cleared 2008-09-11

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

Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504

Reason for recall

The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

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