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Class 2 Device Recall Conductivity Gel |
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| Date Initiated by Firm |
November 03, 2004 |
| Date Posted |
April 22, 2005 |
| Recall Status1 |
Terminated 3 on April 22, 2005 |
| Recall Number |
Z-0719-05 |
| Recall Event ID |
30396 |
| Product Classification |
Transducer, Ultrasonic, Diagnostic - Product Code ITX
|
| Product |
Ultra/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 |
| Action |
All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04. |
| Quantity in Commerce |
121 boxes |
| 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. |
| Total Product Life Cycle |
TPLC Device Report
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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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