Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

LifeStyles Assorted Colors Condoms with Spermicide

FDA Recall Z-0402-03 · Posted 2002-12-31

Recalling FirmAnsell Healthcare Inc
Recall StatusTerminated
Product CodeLTZ
Date Initiated2002-11-25
Date Terminated2003-10-15
Product Quantityapproximately 40 million condoms

Reason for Recall

The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Europe

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000408LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOMSuretex Prophylactics , Ltd. · 2000-04-19K981621ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORSSuretex Prophylactics (India) , Ltd. · 1998-06-19K971132ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORSG. Premjee (Usa), Inc. · 1997-09-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑