SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA 98021 Each
FDA device recall Z-0407-06 · posted 2006-01-19 · Terminated
Recall details
- Recalling firm
- Sonosite, Inc.
- Reason for recall
- 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
- Action taken
- Affected customers were contacted via telephone between December 12-19, 2005. Provided instructions for returning defective product. Notification letter was distributed to all customers on December 14, 2005 instructing customers to discontinue use of the needle guide and return remaining portion.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 355 boxes/24 kits per box
- Distribution
- Product was distributed to distributors and hospitals nationwide and internationally.
- Date initiated
- 2005-12-12
- Date posted
- 2006-01-19
- Date terminated
- 2006-07-31
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY (K030064) | Sonosite,Inc. | 2003-01-22 |