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FDA Classifies Voluntary Notification Related to SC Catheters and IsoMed Pump Incompatibility as Class I Recall
Medtronic, 09/15/09
Medtronic, Inc. announced that the U.S. Food and Drug Administration has classified its letters to physicians related to the incompatibility of its Sutureless Connector intrathecal catheters with the IsoMed® constant–flow infusion pumps as a Class I recall. In the letters, Medtronic informed physicians that the current SC catheter labeling incorrectly states that SC catheters are compatible with the IsoMed infusion pump.
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