LifeStyles Assorted Colors Condoms with Spermicide
FDA device recall Z-0402-03 · posted 2002-12-31 · Terminated
Recall details
- Recalling firm
- Ansell Healthcare Inc
- Reason for recall
- The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LTZ
- Quantity affected
- approximately 40 million condoms
- Distribution
- Nationwide and Europe
- Date initiated
- 2002-11-25
- Date posted
- 2002-12-31
- Date terminated
- 2003-10-15
- Location
- Dothan, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM (K000408) | Suretex Prophylactics , Ltd. | 2000-04-19 |
| ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (K981621) | Suretex Prophylactics (India) , Ltd. | 1998-06-19 |
| ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS (K971132) | G. Premjee (Usa), Inc. | 1997-09-03 |