Recall Z-0717-2013— Ansell Healthcare Products LLC
Class II · Terminated
Class II FDA medical device recall by Ansell Healthcare Products LLC, initiated 2012-11-05, terminated 2013-07-31. It names 3 FDA 510(k) clearances: K000408, K983320, K941258. Product: 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: One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn..
- Recalling firm
- Ansell Healthcare Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-05
- Terminated
- 2013-07-31
- Firm location
- Dothan, AL, United States
510(k) clearances named in this recall
3 on FDA's record- K000408 — LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
- K983320 — ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
- K941258 — LATEX CONDOM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.