Recall Z-0401-03 ยท HIS Condom
Ansell Healthcare Inc
Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors
| Date | Dec 31, 2002 (initiated Nov 25, 2002) |
| Status | Terminated |
| Reason | The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards |
| Root cause | Other |
| Action | Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level. |
| Quantity | approximately 40 million condoms |
| Distribution | Nationwide and Europe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.