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SafetyAlerts
May 28, 2003

Medtronic Has Recalled Lioresal Intrathecal Refill Kits

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Lioresal Intrathecal Refill Kits, Model 8562, (baclofen injection), 10mg/5mL (2000 mcg/mL), 2-5 mL ampules per kit, refill kit/drug prep kit, Rx only. Recall # D-258-3.

CODE
Lot number B03001710N, Exp. Date 03 Feb 05.

RECALLING FIRM/MANUFACTURER
Medtronic, Inc, Minneapolis, MN, by telephone on April 23, 2003. Firm initiated recall is ongoing.

REASON
Lack of assurance of sterility - cracks in refill kit tray (gloves, needles, filter, etc., not drug or drug prep kit).

VOLUME OF PRODUCT IN COMMERCE
68 kits.

DISTRIBUTION
Nationwide.

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.