Device recall
Z-0391-05: Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for…
FDA device recall · Class II · Medtronic Inc, Neurological & Spinal Division
Key facts
| Recall number (Z-number) | Z-0391-05 |
|---|---|
| Recall event | 30503 |
| Product | 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… |
| Product code | LKK |
| Recalling firm | Medtronic Inc, Neurological & Spinal Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 3, 2005 |
| PMA numbers | P860004 |
| FEI number | 2182207 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database