Device recall
Z-2295-2012: Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with…
FDA device recall · Class II · Unimed Surgical Products, Inc.
Key facts
| Recall number (Z-number) | Z-2295-2012 |
|---|---|
| Recall event | 61982 |
| Product | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark… |
| Product code | GEI |
| Recalling firm | Unimed Surgical Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 2012 |
| 510(k) numbers | K944265, K962935 |
| FEI number | 1000307745 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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