Datascope Corporation recalls BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486

Recall date

October 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1713-2018

FDA classification

Class II

Brand / firm

Datascope Corporation

Sold / distributed

Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486