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U.S. Department of Health and Human Services

Class 2 Device Recall Uterine manipulator

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 Class 2 Device Recall Uterine manipulatorsee related information
Date Initiated by FirmMay 12, 2008
Date PostedSeptember 02, 2008
Recall Status1 Terminated 3 on September 25, 2008
Recall NumberZ-1817-2008
Recall Event ID 48115
510(K)NumberK940681 
Product Classification Cannula, Manipulator/Injector, Uterine - Product Code LKF
ProductClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
Code Information Lot Number 080154
FEI Number 1000220650
Recalling Firm/
Manufacturer		 Clinical Innovations, LLC
747 W 4170 S
Salt Lake City UT 84123-1364
For Additional Information Contact
801-268-8200
Manufacturer Reason
for Recall		Inadequate package seal could compromise sterility.
FDA Determined
Cause 2		Process control
ActionConsignees were notified by letter on 05/12/2008 with instructions to conduct the recall to the end user. All remaining product is to be quarantined and returned to CI. A response form was included and a letter template to use in any sub-recall. Contact Richard Dixon at 801-268-8200 if you have questions.
Quantity in Commerce260 units
DistributionCA, CO, FL, MO, OR, VA. Foreign distribution to Mexico and United Kingdom. No military or government distribution.
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 = LKF
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