Recall Z-0402-03 ยท LTZ Condom With Nonoxynol-9
Ansell Healthcare Inc
LifeStyles Assorted Colors Condoms with Spermicide
| 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
| K000408 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM Suretex Prophylactics , Ltd., Apr 19, 2000 |
| K971132 | ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS G. Premjee (Usa), Inc., Sep 3, 1997 |
| K981621 | ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS Suretex Prophylactics (India) , Ltd., Jun 19, 1998 |