Device recall
Z-2276-2009: Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene…
FDA device recall · Class II · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-2276-2009 |
|---|---|
| Recall event | 52730 |
| Product | Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Affected products are SynchroMed II Model 8637 pumps with batteries (MECC Lifetest Batteries)… |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2012 |
| 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