Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex cond...

FDA Device Recall #Z-1249-2017 — Class II — November 22, 2016

Recall Summary

Recall Number Z-1249-2017
Classification Class II — Moderate risk
Date Initiated November 22, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Reckitt Benckiser LLC
Location Parsippany, NJ
Product Type Devices
Quantity 108342 units

Product Description

Durex 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)

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.

Distribution Pattern

Nationwide and Foreign

Lot / 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

Other Recalls from Reckitt Benckiser LLC

Recall # Classification Product Date
Z-0994-2019 Class II Durex Pleasure Pack (60 ct), synthetic polisopr... Dec 19, 2018
Z-0993-2019 Class II Durex Real Feel, synthetic polisoprene male con... Dec 19, 2018
Z-0091-2019 Class II Polyisoprene condomns Product Usage: The Du... Aug 6, 2018
Z-3241-2018 Class II Durex Real Feel Polyisoprene Condoms, 10 count ... Jul 23, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.