22
Apr
2011

Cl ll Prismaflex System

0

Company: Gambro Renal Products, Inc
Date of Enforcement Report 4/20/2011
Class ll:

PRODUCT
Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Recall # Z-1901-2011

REASON
Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter dated March 14, 2011.
Manufacturer: Gambro Lundia Ab – Disposables Division, Lund, Sweden. FDA initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1300 units

DISTRIBUTION
Nationwide

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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