Z-0407-06

SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA...

Name: Z-0407-06 SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA...
Creator: Sonosite, Inc.
Published: 2005-12-12
License: https://open.fda.gov/license/

FUJIFILM SonoSite,Inc. / initiated 2005-12-12 / Terminated / root cause: labeling and UDI

FDA source

Sonosite, Inc. began a recall of 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... on 2005-12-12. The reason FDA records is "22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0407-06
Status: Terminated
Initiated: 2005-12-12
Posted: 2006-01-19
Terminated: 2006-07-31
Recalling firm: FUJIFILM SonoSite,Inc.
Product: 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
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
Root cause tag: labeling and UDI
FDA 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 in commerce: 355 boxes/24 kits per box
Distribution: Product was distributed to distributors and hospitals nationwide and internationally.
Product codes and lots: 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

Product code ITX

K030064Class IIIlook 25 Needle Guide Attachment and Bracket AssemblySonosite,Inc. / cleared 2003-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)