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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile needle guide kit

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 Class 2 Device Recall Sterile needle guide kitsee related information
Date Initiated by FirmNovember 03, 2004
Date PostedApril 22, 2005
Recall Status1 Terminated 3 on April 22, 2005
Recall NumberZ-0714-05
Recall Event ID 30396
Product Classification Transducer, Ultrasonic, Diagnostic - Product Code ITX
ProductSite-Rite Sterile Needle Guide Kit - 18 gauge
Code Information 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.
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
ActionAll domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.
Quantity in Commerce46,141 units
DistributionNationwide. 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 CycleTPLC 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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