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FDA Enforcement Report
http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.html
PRODUCT
Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722, Recall # Z-1007-2007
CODE
All serial numbers for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by letters on April 24, 2007. Firm initiated recall is ongoing.
REASON
Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemia.
VOLUME OF PRODUCT IN COMMERCE
334,000 pumps
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Ascensia Contour Blood Glucose Monitoring System (Bayer) Diabetes Care System; Product 7152A, Recall # Z-1001-2007
CODE
Serial numbers 1475139, 1688643, 1841620, 1852071, 2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037 and 2319010
RECALLING FIRM/MANUFACTURER
Bayer Healthcare LLC, Mishawaka, IN, by telephone on June 6, 2007 and by e-mail on June 12, 2007. Firm initiated recall is ongoing.
REASON
Incorrect Unit of Measure displayed: The meters report results in the wrong unit of measurement for Canadian users.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Canada
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