Site-Rite Sterile Ultrasound Probe Cover with Gel
- Company
- Bard Access Systems, Inc.
- Recall Initiated
- November 3, 2004
- Posted
- April 22, 2005
- Terminated
- April 22, 2005
- Recall Number
- Z-0717-05
- Quantity
- 121,435 units
- Firm Location
- Salt Lake City, UT
Reason for Recall
Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
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.
Lot / Code Info
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,.
Root Cause
Other
Action Taken
All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.