Z-0717-2013 Class II Terminated

Recalled by Ansell Healthcare Products LLC — Dothan, AL

FDA device recall Z-0717-2013 was initiated by Ansell Healthcare Products LLC on November 5, 2012 and is designated Class II. Reason for recall: One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn. The recall status is terminated (terminated July 31, 2013). Affected quantity: 445 cases (10680 consumer units).

Recall Details

Product Type
Devices
Report Date
January 30, 2013
Initiation Date
November 5, 2012
Termination Date
July 31, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
445 cases (10680 consumer units)

Product Description

Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.

Reason for Recall

One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.

Distribution Pattern

Nationwide Distribution.

Code Information

Lot Code: 120921021C