FDA recall Z-0266-2020

Datascope Corp. · Class II · device

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 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.

Distribution

Distributed to CA, GA, and TX.

Key facts

Status
Terminated
Initiation date
2019-10-03
Report date
2019-11-13
Termination date
2021-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0266-2020