Device recall
Z-2295-2013: MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable…
FDA device recall · Class I · Codman & Shurtleff, Inc.
Key facts
| Recall number (Z-number) | Z-2295-2013 |
|---|---|
| Recall event | 65821 |
| Product | MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the… |
| Product code | LKK |
| Recalling firm | Codman & Shurtleff, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 11, 2014 |
| PMA numbers | P890055 |
| FEI number | 3002947440 |
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