Device recall
Z-2198-2013: ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the…
FDA device recall · Class II · Assuramed
Key facts
| Recall number (Z-number) | Z-2198-2013 |
|---|---|
| Recall event | 65980 |
| Product | ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test… |
| Product code | GJS |
| Recalling firm | Assuramed |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2017 |
| 510(k) numbers | K010599 |
| FEI number | 3009929723 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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