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U.S. Department of Health and Human Services

Class 2 Device Recall Lover

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  Class 2 Device Recall Lover see related information
Date Initiated by Firm March 25, 2005
Date Posted June 21, 2005
Recall Status1 Terminated 3 on April 17, 2007
Recall Number Z-0911-05
Recall Event ID 31500
Product Lover brand lubricated latex condoms, spermicidal, Nuevo Innovations, Farmingdale, NY ; item number 29043.
Code Information All lots.
Recalling Firm/
Manufacturer		 Harmony Brands Llc
13240 Capital St
Oak Park MI 48237-3159
For Additional Information Contact Sonia Mackie
248-582-9800
Manufacturer Reason
for Recall		 Lack of assurance of safety and efficacy; products are from unknown sources.
FDA Determined
Cause 2		 Other
Action Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.
Quantity in Commerce unknown.
Distribution United States .
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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