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U.S. Department of Health and Human Services

Class 2 Device Recall Durex Real Feel, Durex Synthetic

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  Class 2 Device Recall Durex Real Feel, Durex Synthetic see related information
Date Initiated by Firm July 23, 2018
Create Date September 24, 2018
Recall Status1 Terminated 3 on March 05, 2020
Recall Number Z-3241-2018
Recall Event ID 80841
510(K)Number K072169  
Product Classification Condom, synthetic - Product Code MOL
Product Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00

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 Batch Numbers: 1000427177, 1000408620, 1000430764
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		 The products failed the filed specification of 1.0kPa for Burst Pressure.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 7/23/18, an Urgent Medical Device Recall notification letter was distributed to customers. The letter instructed customers to do the following: 1. Examine your inventory in your distribution center immediately to determine if you have the specified batch in your warehouse inventory. 2. Segregate and quarantine the specified batch. 3. If you have product of the specified batch, contact our Stericycle representative immediately for a RETURN AUTHORIZATION number. a. Contact Information: Phone: 877-448-5308 Fax: 877-884-9410 4. Contact Stericycle Expert Solutions at 877-448-5308 for assistance with coordination of pickup and removal of product from your facility. If arranging pick up of product, freight will be prepaid by Stericycle. A pre-paid return label has been included for your convenience. Alternatively, you may arrange shipment of product directly to Stericycle at the following address: Attn: Event 4241 2670 Executive Drive, Suite A Indianapolis, IN 46241 Dock Hours are SAM -4:30PM Monday- Friday Please call to schedule a dock appointment 5. Finally, notify Stericycle representative via email RB4241@stericycle.com that you have: a. Checked your inventory in your distribution centers and confirm you have NO product of the specified batch b. You have collected all units in your inventory and product has been shipped back in accordance with the instructions from your Stericycle representative. On 7/26/18, a second Urgent Medical Device Recall notification letter was sent to customers which included two additional batches included in the recall. This letter included the same customer instructions as the 7/23/18 letter.
Quantity in Commerce 487980 condoms
Distribution US Nationwide.
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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