Medtronic Neuromodulation Recall: Refill Kit 8551/856X (includes Models 8561, 8562 and 856
Medtronic Neuromodulation Recall: Refill Kit 8551/856X (includes Models 8561, 8562 and 856 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Neuromodulation; Product: Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infu
| Recalling firm | Medtronic Neuromodulation |
|---|---|
| Product | Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps. |
| Reason for recall | Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama. |
| Recall initiated | 20140404 |
| Recall number | Z-1568-2014 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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