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U.S. Department of Health and Human Services

Class 3 Device Recall Cleaning probe

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  Class 3 Device Recall Cleaning probe see related information
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
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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