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
This recall has been terminated (originally issued January 19, 2006).
- Company
- Sonosite, Inc.
- Recall Initiated
- December 12, 2005
- Posted
- January 19, 2006
- Terminated
- July 31, 2006
- Recall Number
- Z-0407-06
- Quantity
- 355 boxes/24 kits per box
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
Distribution
Product was distributed to distributors and hospitals nationwide and internationally.
Lot / Code Info
Box Lot Code: M778940; M779110; M785430; M790190; M791960; M793010; M793020; M793530; M799610; M799620; M803570; M803580; M806400; M806410; M806420; M809020; M810990; M823040; M830430. Pouch Lot Code: M761640; M778400; M781250; M783140; M785270; M791720; M797960; M801010; M802700; M804630; M807010; M811660; M831060; M832790
Root Cause
Other
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.