FDA recall Z-1490-2019

Product

McKesson Cardiology Hemo

Reason for recall

users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician s Report as well as customers, who have implemented an outbound interface of procedure results.

Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WY. International distribution to Australia, Canada, Germany, Ireland, Israel, United Kingdom.

Key facts

Status

Terminated

Initiation date

2019-03-25

Report date

2019-06-05

Termination date

2025-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Holon, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2019