Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Sterile needle guide kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 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-0716-05
Recall Event ID 30396
Product Classification Transducer, Ultrasonic, Diagnostic - Product Code ITX
ProductSite-Rite Sterile Needle Guide Kit - 21 Gauge
Code Information Product Code 90013B01. Lot Numbers 61189, 61219, 61280, 61302, 61332, 63141, 63147, 63171, 63245, 63262, 63339, 63360, 63401, 63421, 63422, 63450, 63451, 63521, 63538, 63590, 63615, 63666, 63723, 63729, 63770, 63814, 63830, 63862, 63913, 63925, 63991, 63998, 64028, 64063, 64080, 64137, 64151, 64192, 64218, 64229, 64261, 64289, 64330, 64353, 64375, 64401, 64447, 64492, 64550, 64591.
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 Commerce27,721 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.
-
-