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U.S. Department of Health and Human Services

Class 2 Device Recall Conductivity Gel

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 Class 2 Device Recall Conductivity Gelsee related information
Date Initiated by FirmNovember 03, 2004
Date PostedApril 22, 2005
Recall Status1 Terminated 3 on April 22, 2005
Recall NumberZ-0719-05
Recall Event ID 30396
Product Classification Transducer, Ultrasonic, Diagnostic - Product Code ITX
ProductUltra/Phonic Conductivity Gel, 20 ml. Each unit is a foil to foil pouch. Product is packaged 25 pouches per box.
Code Information Product Code 9001C0200. Lot Numbers 021404-4, 010904, 091403, 060303, 050403, 011003, 071202, 111300, 120998, 021202, 100101, 112703, 011202, 091398, 080900, 060500. 
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, 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 Commerce121 boxes
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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