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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 probesee related information
Date Initiated by FirmMay 18, 2007
Date PostedAugust 07, 2007
Recall Status1 Terminated 3 on August 22, 2011
Recall NumberZ-1130-2007
Recall Event ID 38373
510(K)NumberK960330 
Product Classification Cleaning probe for disposable catheters - Product Code LLZ
ProductCleaning 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
ActionConsignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes.
Quantity in Commerce67,625 units
DistributionWorldwide, including USA, Canada and France.
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.
510(K) Database510(K)s with Product Code = LLZ
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