Device recall
Z-0030-2009: Platinum Plus" LT, REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with…
FDA device recall · Class III · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0030-2009 |
|---|---|
| Recall event | 49462 |
| Product | Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire… |
| Product code | DQX |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 10, 2011 |
| 510(k) numbers | K935997, K945379 |
| FEI number | 3002095335 |
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