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 IS INTACT. Mfg for: Sonosite, Inc. 888/482-9449*425/951-1200, Bothell, WA 98021 USA. www.sonosi Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.sonosi
Brand
Sonosite, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Sonosite, Inc. is recalling SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., due to 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026