May 28, 2003
Medtronic Has Recalled Lioresal
Intrathecal Refill Kits
The Food and Drug Administration (FDA) released the following information.
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.
Lot number B03001710N, Exp. Date 03 Feb 05.
Medtronic, Inc, Minneapolis, MN, by telephone on April 23, 2003. Firm
initiated recall is ongoing.
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