McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clini
FDA device recall Z-0093-2015 · posted 2014-10-20 · Terminated
Recall details
- Recalling firm
- Mckesson Information Solutions LLC
- Reason for recall
- McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i
- Action taken
- Consignees were notified via Field Safety Notice on 06/25/2014.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 625 devices
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.
- Date initiated
- 2014-06-25
- Date posted
- 2014-10-20
- Date terminated
- 2017-10-26
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCKESSON CARDIOLOGY HEMO (K131497) | Mckesson Israel , Ltd. | 2013-12-05 |