Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed famil
FDA device recall Z-0391-05 · posted 2005-01-13 · Terminated
Recall details
- Recalling firm
- Medtronic Inc, Neurological & Spinal Division
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LKK
- Quantity affected
- 96 kits were distributed to 34 customers
- Distribution
- within the United States only
- Date initiated
- 2004-11-19
- Date posted
- 2005-01-13
- Date terminated
- 2005-11-03
- Location
- Columbia Heights, MN
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