Jul

2001

Sabratek Corp. Class II

Date of Enforcement Report: 7/11/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0629-1, Multi-Therapy Ambulatory Infusion Pumps sold under the following labels
a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40
(English), 606000-40L (loaner pump) and 606000-40I (International)
b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code
2M9832

REASON:
Potential overinfusion in the Auto-Ramp mode with software ver. 3.00 or higher

MANUFACTURER:
Sabratek Corp. Skokie, IL

RECALLED BY:
Baxter Healthcare Corp., I.V. Systems Div. Round Lake, IL by letter on February 20, 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide, United Kingdom, France, Germany, Portugal, Canada, Ireland, Brazil, Japan, Argentina, Sweden, Austria, New Zealand and Chile

QUANTITY
15,000

About the author

Amy Sellers

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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Sabratek Corp. Class II

Amy Sellers

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