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U.S. Department of Health and Human Services

Class 2 Device Recall Durex

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 Class 2 Device Recall Durexsee related information
Date Initiated by FirmNovember 22, 2016
Create DateFebruary 23, 2017
Recall Status1 Terminated 3 on January 15, 2020
Recall NumberZ-1249-2017
Recall Event ID 75829
Product Classification Condom - Product Code HIS
ProductDurex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)
Code Information 3ct - item code 02340-30042-04  lot code exp date   3 ct - Walmart item code 02340-70042-04  lot code exp date   12ct - item code 02340-30274-08  lot code exp date   24 ct - item code 02340-302190-04  lot codes and exp date
Recalling Firm/
Manufacturer		 Reckitt Benckiser LLC
399 Interpace Pkwy
Parsippany NJ 07054-1133
For Additional Information ContactStericycle Expert Solutions
877-830-9730
Manufacturer Reason
for Recall		Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
FDA Determined
Cause 2		Error in labeling
ActionReckitt Benckiser LLC sent an Urgent Medical Device Recall letter/business response form dated November 22, 2016 to the affected customers. Stericylcle is handling returns.
Quantity in Commerce108342 units
DistributionNationwide and Foreign
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.
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