Device recall
Z-0718-2007: Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP…
FDA device recall · Class III · Smiths Medical MD, Inc.
Key facts
| Recall number (Z-number) | Z-0718-2007 |
|---|---|
| Recall event | 37486 |
| Product | Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD, Inc., St. Paul, MN 55112 USA; RX ONLY. |
| Product code | FRN |
| Recalling firm | Smiths Medical MD, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 25, 2007 |
| 510(k) numbers | K000842, K960826 |
| 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