Device recall
Z-0146-2011: Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library…
FDA device recall · Class I · Sigma International General Medical Apparatus, Llc
Key facts
| Recall number (Z-number) | Z-0146-2011 |
|---|---|
| Recall event | 56833 |
| Product | Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc… |
| Product code | FRN |
| Recalling firm | Sigma International General Medical Apparatus, Llc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 28, 2017 |
| 510(k) numbers | K042121 |
| FEI number | 1314492 |
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