Date Initiated by Firm |
December 12, 2005 |
Date Posted |
January 19, 2006 |
Recall Status1 |
Terminated 3 on July 31, 2006 |
Recall Number |
Z-0407-06 |
Recall Event ID |
34250 |
510(K)Number |
K030064
|
Product Classification |
Transducer, Ultrasonic, Diagnostic - Product Code ITX
|
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 |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Sonosite, Inc. 21919 30th Dr Se Bothell WA 98021-3904
|
For Additional Information Contact |
Daina L. Graham 425-951-1201
|
Manufacturer Reason for Recall |
22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = ITX and Original Applicant = SONOSITE,INC.
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