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Class 2 Device Recall Durex Real Feel |
 |
| Date Initiated by Firm |
December 19, 2018 |
| Date Posted |
March 09, 2019 |
| Recall Status1 |
Terminated 3 on March 26, 2021 |
| Recall Number |
Z-0993-2019 |
| Recall Event ID |
81964 |
| 510(K)Number |
K072169
|
| Product Classification |
Condom, synthetic - Product Code MOL
|
| Product |
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
|
| Code Information |
1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098 |
Recalling Firm/
Manufacturer |
Reckitt Benckiser LLC
399 Interpace Pkwy
Parsippany NJ 07054-1133
|
Manufacturer Reason
for Recall |
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| 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: rbhealth3552@stericycle.com
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 rbhealth3552@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.
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. |
| Quantity in Commerce |
1761044 |
| Distribution |
Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten. |
| Total Product Life Cycle |
TPLC Device Report
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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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| 510(K) Database |
510(K)s with Product Code = MOL and Original Applicant = SSL AMERICAS, INC.
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