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Recall Observatory FDA recall evidence

Device 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.

Z-0717-2013

November 05, 2012

Class II

Product summary

Firm
Ansell Healthcare Products LLC
Event
Event 63873
Status
Terminated
Classification
Class II
Quantity
445 cases (10680 consumer units)
Official record key
device-enforcement:Z-0717-2013

Official wording

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

Code information: Lot Code: 120921021C

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    misbranded