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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasound Probe Cover

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  Class 2 Device Recall Ultrasound Probe Cover 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-0717-05
Recall Event ID 30396
Product Classification Transducer, Ultrasonic, Diagnostic - Product Code ITX
Product Site-Rite Sterile Ultrasound Probe Cover with Gel
Code Information Product Code 9001C0197. Lot numbers 61177, 61189, 61211, 61219, 61250, 61280, 61293, 61304, 63141, 63147, 63200, 63210, 63235, 63269, 63304, 63324, 63357, 63372, 63375, 63398, 63409, 63421, 63442, 63450, 63458, 63494, 63505, 63533, 63558, 63559, 63584, 63590, 63616, 63634, 63685, 63723, 63750, 63782, 63798, 63824, 63846, 63895, 63913, 63933, 63952, 63981, 64006, 64024, 64028, 64029, 64053, 64079, 64094, 64109, 64126, 64137, 64147, 64148, 64163, 64183, 64205, 64206, 64220, 64228, 64236, 64257, 64290, 64305, 64317, 64318, 64329, 64351, 64352, 64376, 64377, 64400, 64434, 64459, 64512, 64540, 64586, 64606, 64645, 64646,.
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 121,435 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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