FDA Recall Terminated

Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00

Recall: Z-0993-2019 · Initiated December 19, 2018

Recall

Recall Number: Z-0993-2019
Event Number: 81964
Firm: Reckitt Benckiser LLC
FEI Number: 3011015568
Product Code: MOL
Status: Terminated
Root Cause: Under Investigation by firm
Initiated: December 19, 2018
Posted: March 9, 2019
Terminated: March 26, 2021
Address: 399 Interpace Pkwy, Parsippany, NJ, 07054-1133

Description

Reason

Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

Action

On December 19, 2018, the firm issued Urgent Medical Device Recall letters to wholesale customers. The letter advised customers of the product issue, and reminded customers that the product labeling states, "Should a condom break or leak during use, seek medical assistance as soon as possible, at least within 72 hrs." Customers are asked to do the following: 1. Examine inventory in your distribution center immediately to determine if you have the specified batch in your warehouse inventory. 2. Segregate and return the specified batch. 3. A pre-paid return label is provided by the firm for your convenience to return the product. Contact Stericycle Expert Solutions at 888-843-0252 for assistance if you need additional labels or help with coordination of pickup and removal of product from your facility. Contact Information: Phone: 888-843-0252 Fax: 855-880-6687 Email: [email protected] 4. Alternatively, you may arrange shipment of product directly to Stericycle at the following address: Attn: Event 3552 2670 Executive Drive, Suite A Indianapolis, IN 46241 Dock Hours are 8AM - 4:30PM Monday - Friday Please call to schedule a dock appointment 5. Finally, notify Stericycle representative by completing and returning the Business Response Form via email [email protected] 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. Please direct any questions or concerns with this recall to Stericycle Representative at 877-448-5308 and reference event 3552. For general inquiry not related to the recall, please contact RB Custo er Service Director, Robert Drennan at 201-220-8531.

Distribution

Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.

Quantity

1761044