Medical device recalls Moderate risk

Datascope Corp. recalls Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs…

Recall date
October 3, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0266-2020
FDA classification
Class II
Brand / firm
Datascope Corp.
Sold / distributed
Distributed to CA, GA, and TX.

Why it was recalled

One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.

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

What was recalled

Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

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