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 IS INTACT. Mfg for: Sonosite, Inc. 888/482-9449*425/951-1200, Bothell, WA 98021 USA. www.sonosite.com
Recall
- Recall Number
- Z-0407-06
- Event Number
- 34250
- Firm
- Sonosite, Inc.
- FEI Number
- 3002087856
- Product Code
- ITX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 12, 2005
- Posted
- January 19, 2006
- Terminated
- July 31, 2006
- Address
- 21919 30th Dr Se, Bothell, WA, 98021-3904
Description
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 IS INTACT. Mfg for: Sonosite, Inc. 888/482-9449*425/951-1200, Bothell, WA 98021 USA. www.sonosite.com
22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
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.
Product was distributed to distributors and hospitals nationwide and internationally.
355 boxes/24 kits per box