13
Jul
2005

Baxter Healthcare Renal Div. Class III

0

Company: Baxter Healthcare Renal Div,
Date of Enforcement Report: 7/13/05
Class: III

PRODUCT
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R, Recall # Z-0947-05

REASON
The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.

CODE
All serial numbers with software version 4.0 or below

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div, McGaw Park, IL, no official recall notification was made. Meridian software version 4.12 was released on 10/3/03 and was implemented as a reliability improvement initiative to all Meridian customers. Shipment of 4.12 software was completed in November 2003.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is complete

VOLUME OF PRODUCT IN COMMERCE
2986 units

DISTRIBUTION
Nationwide, Korea, Mexico, Guatemala, China and Hong Kong

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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