Inc ClassII Alaris Medical Systems

Company: ALARIS MEDICAL SYSTEMS, INC
Date of Enforcement Report: 8/22/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-748-1, Model PC-1 A one channel, general purpose, infusion pump, 220V CE Marked, International only (Software version 8.12 and 8.13)

REASON:
Motor stall

MANUFACTURER/RECALLING FIRM:
ALARIS MEDICAL SYSTEMS, INC., San Diego, CA

RECALLED BY:
International mailings are being coordinated by Alaris Medical UK, Ltd. located in Basingstoke, UK.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
International and U.S. Defense Department under contracts V797P-4091A and
SP0200-98-D-8002.

QUANTITY:
5820

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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