Z-1249-2017 Class II Terminated
FDA device recall Z-1249-2017 was initiated by Reckitt Benckiser LLC on November 22, 2016 and is designated Class II. 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. The recall status is terminated (terminated January 15, 2020). Affected quantity: 108342 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 1, 2017
- Initiation Date
- November 22, 2016
- Termination Date
- January 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
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