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U.S. Department of Health and Human Services

Class 2 Device Recall KY True Feeling

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  Class 2 Device Recall KY True Feeling see related information
Date Initiated by Firm August 06, 2018
Create Date October 10, 2018
Recall Status1 Terminated 3 on November 12, 2019
Recall Number Z-0091-2019
Recall Event ID 80939
510(K)Number K072169  
Product Classification Condom, synthetic - Product Code MOL
Product Polyisoprene condomns

Product Usage:
The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Code Information Lot Number - 1000490884
Recalling Firm/
Manufacturer		 Reckitt Benckiser LLC
399 Interpace Pkwy
Parsippany NJ 07054-1133
For Additional Information Contact Lynn Kenney
973-404-2494
Manufacturer Reason
for Recall		 Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On August 6,. 2018, Reckitt Benckiser issued Urgent Medical Device Recall notices to customers. Customers were advised to take the following action: Wholesale Customers: 1. Examine inventory and quarantine affected product 2. Contact customers and notify them of the recall and provide them with the recall instructions (copy of the letter). 3. Customers are encouraged to contact Stericycle Expert Solutions at 877-448-5308 for assistance if additional return labels are required or help with coordination of pickup and removal of product from your facility.
Quantity in Commerce 34 cartons/12 condoms each (408 condoms total)
Distribution US in the states of NY
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.
510(K) Database 510(K)s with Product Code = MOL and Original Applicant = SSL AMERICAS, INC.
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