Device recall
Z-0265-2010: Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For…
FDA device recall · Class II · Sharn, Inc.
Key facts
| Recall number (Z-number) | Z-0265-2010 |
|---|---|
| Recall event | 53497 |
| Product | Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA. REF: LTAD-PL7-25, Lot 121508, packed 25 per package. REF: LTAD-PL7-100, Lot 121508, packed 100 per package. Southmedic 50 alliance Blvd., Barrie, Ontario… |
| Product code | CCT |
| Recalling firm | Sharn, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2012 |
| 510(k) numbers | K070596 |
| FEI number | 3020651884 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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