| Class 2 Device Recall Ultrasound Cover Kit | |
Date Initiated by Firm | November 03, 2004 |
Date Posted | April 22, 2005 |
Recall Status1 |
Terminated 3 on April 22, 2005 |
Recall Number | Z-0718-05 |
Recall Event ID |
30396 |
Product Classification |
Transducer, Ultrasonic, Diagnostic - Product Code ITX
|
Product | Intraoperative Ultrasound Cover Kit |
Code Information |
Product Code 900023B01. Lot numbers 61233, 63200, 63235, 63263, 63270, 63324, 63357, 63375, 63401, 63409, 63414, 63451, 63458, 63515, 63530, 63559, 63612, 63615, 63646, 63674, 63770, 63824, 63875, 63953, 63998, 64080, 64191, 64258, 64269, 64289, 64317, 64493, 64586, 64646. |
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 kits 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 | 8,561 units |
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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