Recall Z-0266-2020— Datascope Corp.

Name: FDA recall Z-0266-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-03

Class II · Terminated

Class II FDA medical device recall by Datascope Corp., initiated 2019-10-03, terminated 2021-01-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging..

Recalling firm: Datascope Corp.
Classification: Class II
Status: Terminated
Initiated: 2019-10-03
Terminated: 2021-01-08
Firm location: Mahwah, NJ, United States

Product description

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

Reason for recall

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

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