Recall Z-0391-05 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Inc, Neurological & Spinal Division
Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray. Lioresal drug ampules contained witin Medtronic Lot N0016487 bear the primary manufacturer''s label and lot number 007J2
| Date | Jan 13, 2005 (initiated Nov 19, 2004) |
| Status | Terminated |
| Reason | Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml). |
| Root cause | Other |
| Action | Customers were contacted 11/19/04 via telephone. Customers were asked to set aside product and return the affected lot to Medtronic, Inc., Moundsview, MN. Recalled product will be replaced by Medtronic. |
| Quantity | 96 kits were distributed to 34 customers |
| Distribution | within the United States only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.