Date Initiated by Firm |
May 18, 2007 |
Date Posted |
August 07, 2007 |
Recall Status1 |
Terminated 3 on August 22, 2011 |
Recall Number |
Z-1130-2007 |
Recall Event ID |
38373 |
510(K)Number |
K960330
|
Product Classification |
Cleaning probe for disposable catheters - Product Code LLZ
|
Product |
Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV. |
Code Information |
No manufacturing or serial numbers. |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact |
801-328-9300
|
Manufacturer Reason for Recall |
Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes. |
Quantity in Commerce |
67,625 units |
Distribution |
Worldwide, including USA, Canada and France. |
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.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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