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
FDA Recall Z-0407-06 · Posted 2006-01-19
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Recalling FirmSonosite, Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2005-12-12
Date Terminated2006-07-31
Product Quantity355 boxes/24 kits per box
Reason for Recall
22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to distributors and hospitals nationwide and internationally.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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