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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile needle guide kit

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  Class 2 Device Recall Sterile needle guide kit see related information
Date Initiated by Firm November 03, 2004
Date Posted April 22, 2005
Recall Status1 Terminated 3 on April 22, 2005
Recall Number Z-0715-05
Recall Event ID 30396
Product Classification Transducer, Ultrasonic, Diagnostic - Product Code ITX
Product Site-Rite Sterile Needle Guide Kit - 20 gauge
Code Information Product Code 9001C0214. Lot numbers: 61187, 61233, 61258, 61302, 61332, 63189, 63220, 63245, 63270, 63339, 63360, 63398, 63401, 63402, 63422, 63451, 63515, 63521, 63538, 63564, 63612, 63615, 63666, 63729, 63766, 63783, 63830, 63862, 63925, 63957, 63973, 64042, 64094, 64108, 64148, 64182, 64218, 64229, 64258, 64261, 64268, 64378, 64419, 64420, 64440, 64460, 64493.
Recalling Firm/
Manufacturer		 Bard Access Systems, Inc
5425 Amelia Earhart Dr
Salt Lake City UT 84116-3713
For Additional Information Contact
801-595-0700
Manufacturer Reason
for Recall		 Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
FDA Determined
Cause 2		 Other
Action All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.
Quantity in Commerce 34,619 units
Distribution Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.
Total Product Life Cycle TPLC Device Report
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.
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