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U.S. Department of Health and Human Services

Class 2 Device Recall ConceivEase

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  Class 2 Device Recall ConceivEase see related information
Date Initiated by Firm July 10, 2009
Date Posted August 27, 2009
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-1904-2009
Recall Event ID 52725
Product Classification Patient Latex Compatible Vaginal Lubricant - Product Code NUC
Product ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN

Intended Use: Personal Lubricant.
Code Information lot: WK0608
Recalling Firm/
Manufacturer		 Memphis Fertility Laboratory Inc
80 Humphreys Center Drive
Suite 307
Memphis TN 38120-2363
For Additional Information Contact William H. Kutteh, MD
901-747-2229
Manufacturer Reason
for Recall		 Product was marketed without a 510(k).
FDA Determined
Cause 2		 PMA
Action The firm notified its sole consignee on 07/10/2009 by telephone and followed by an Urgent Medical Device Recall letter. The letter requested that they examine their inventory and quarantine all products subject to recall and immediately contact Dr. William Kutteh for return instructions. The enclosed response form should be completed and returned. Questions should be directed to Dr. Kutteh at 901-261-2401.
Quantity in Commerce 800 units
Distribution Nationwide Distribution -- USA, including the state of MA.
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.
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