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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:115660

LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

Official recall number

Z-0838-2013

Evidence summary

Product code
HIS
Recall status
Terminated
Event initiated
January 14, 2013
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0838-2013