Site-Rite Sterile Needle Guide Kit - 18 gauge
- Company
- Bard Access Systems, Inc.
- Recall Initiated
- November 3, 2004
- Posted
- April 22, 2005
- Terminated
- April 22, 2005
- Recall Number
- Z-0714-05
- Quantity
- 46,141 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 9001C0212. Lot numbers: 61208, 61233, 61258, 61287, 61308, 63189, 63220, 63225, 63263, 63305, 63338, 63360, 63383, 63402, 63414, 63442, 63472, 63515, 63530, 63564, 63597, 63646, 63720, 63766, 63783, 63817, 63845, 63875, 63924, 63953, 63991, 64056, 64063, 64125, 64164, 64191, 64258, 64261, 64269, 64330, 64364, 64401, 64420, 64433, 64448, 64452, 64514, 64652.
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.