Device recall
Z-1605-2008: Deltec Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical…
FDA device recall · Class II · Smiths Medical MD, Inc.
Key facts
| Recall number (Z-number) | Z-1605-2008 |
|---|---|
| Recall event | 47482 |
| Product | Deltec Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK. Reorder number 21-5311-01 The product is used for general drug delivery infusion therapies. The product is only intended to be used by trained clinicians. |
| Product code | FRN |
| Recalling firm | Smiths Medical MD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K940446 |
| FEI number | 2183502 |
At a glance
- 1–9 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