12
May
2004

Hudson Respiratory Care Inc. Class II

0

Company: Hudson Respiratory Care Inc.
Date of Enforcement Report: 5/12/04
Class: II

PRODUCT
Concha IV Plus Heated Humidifier. Recall # Z-0929-04.

REASON
Software malfunction.

CODE
All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field.

RECALLING FIRM/MANUFACTURER
Hudson Respiratory Care Inc, Temecula , CA , by visit beginning on February 20, 2004 . Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1049.

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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