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
