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.
(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.
