Site-Rite Sterile Needle Guide Kit - 20 gauge
- Company
- Bard Access Systems, Inc.
- Recall Initiated
- November 3, 2004
- Posted
- April 22, 2005
- Terminated
- April 22, 2005
- Recall Number
- Z-0715-05
- Quantity
- 34,619 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 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.
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.