Recall Z-0407-06 ยท ITX Transducer, Ultrasonic, Diagnostic
Sonosite, Inc.
SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA 98021 Each kit is packaged in a hermetically sealed clear plastic pouch with white backing. Product is labeled as Sterile. 24 pouches are packaged in a white cardboard box and labeled as SonoSite L25 Needle Guide Kit, 21 GAUGE REF# P04053-01, Quantity: 24, CONTENTS STERILE IF PACKAGE
| Date | Jan 19, 2006 (initiated Dec 12, 2005) |
| Status | Terminated |
| Reason | 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides. |
| Root cause | Other |
| Action | 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. |
| Quantity | 355 boxes/24 kits per box |
| Distribution | Product was distributed to distributors and hospitals nationwide and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY Sonosite,Inc., Jan 22, 2003 |