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U.S. Department of Health and Human Services

Class 2 Device Recall Site Rite Systems containing needle guide kits.

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  Class 2 Device Recall Site Rite Systems containing needle guide kits. 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-0720-05
Recall Event ID 30396
Product Classification Transducer, Ultrasonic, Diagnostic - Product Code ITX
Product Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.
Code Information Site Rite II System - Item Numbers: 9740001-9740006. Serial number ranges: 32563-32624, 33450-33549, 35900-35999, 37300-37399, 37950-38028.  Site Rite 3 System - Item Numbers: 9740010-9740019. Serial number ranges: 32774-32974, 34900-35149, 36100-36199, 36450-36510, A02001-A02383.  Site Rite IV System - Item Numbers: 9740050-9740052, 9740059, 9740091, 9760004, 9760018. Serial number ranges: B03001-B03588, B03590-B03601, B03603-B03607, B03609, B03632, B03636, B03647.
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, 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 2360 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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