Device recall
Z-1400-2015: CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene…
FDA device recall · Class II · Civco Medical Instruments Inc
Key facts
| Recall number (Z-number) | Z-1400-2015 |
|---|---|
| Recall event | 70719 |
| Product | CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover… |
| Product code | ITX |
| Recalling firm | Civco Medical Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2017 |
| 510(k) numbers | K013721 |
| FEI number | 1937223 |
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