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U.S. Department of Health and Human Services

Class 2 Device Recall LifeStyles Assorted Colors with Spermicide

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 Class 2 Device Recall LifeStyles Assorted Colors with Spermicidesee related information
Date Initiated by FirmNovember 25, 2002
Date PostedDecember 31, 2002
Recall Status1 Terminated 3 on October 15, 2003
Recall NumberZ-0402-03
Recall Event ID 25095
510(K)NumberK000408 K971132 K981621 
Product Classification Condom With Nonoxynol-9 - Product Code LTZ
ProductLifeStyles Assorted Colors Condoms with Spermicide
Code Information ANSELL HEALTHCARE INC.    LOT NUMBER PRODUCT CODE DESCRIPTION  0912C01622 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01522 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01422 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01322 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01222 6000 LS ASST CLRS W/SPL STPS 1000''S 0912C01122 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00322 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00222 6000 LS ASST CLRS W/SPL STPS 1000''S 0911C00122 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02222 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02122 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C02022 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01922 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01822 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01722 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01622 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01522 6000 LS ASST CLRS W/SPL STPS 1000''S 0910C01422 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C02722 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C02522 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00722 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00622 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00522 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00422 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00322 6000 LS ASST CLRS W/SPL STPS 1000''S 0909C00222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04122 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C04022 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03922 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03222 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C03022 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02922 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02822 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02722 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02622 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02522 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02422 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02322 6000 LS ASST CLRS W/SPL STPS 1000''S 0908C02222 6000 LS ASST CLRS W/SPL STPS 1000''S  0001990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0001990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0001991622 6000 LS ASST CLRS W/SPL STPS 1000''S 0001991922 6000 LS ASST CLRS W/SPL STPS 1000''S 0001992122 6000 LS ASST CLRS W/SPL STPS 1000''S 0002990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0002990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990622 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990722 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0004990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990122 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990222 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990322 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990422 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990522 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990622 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990722 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990822 6000 LS ASST CLRS W/SPL STPS 1000''S 0005990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0005991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0006991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991122 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991322 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991422 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991522 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991622 6000 LS ASST CLRS W/SPL STPS 1000''S 0007991722 6000 LS ASST CLRS W/SPL STPS 1000''S 0008990622 6003 LS ASST COLORS W/SPL FP 3''S 0008990922 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991022 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991122 6000 LS ASST CLRS W/SPL STPS 1000''S 0008991222 6000 LS ASST CLRS W/SPL STPS 1000''S 0008992022 6000 LS ASST CLRS W/SPL STPS 1000''S 0009991322 6003 LS ASST COLORS W/SPL FP 3''S 0009992122 6003 LS ASST COLORS W/SPL FP 3''S 0009992222 6003 LS ASST COLORS W/SPL FP 3''S 0106992622 6000 LS ASST CLRS W/SPL STPS 1000''S 0106992722 6000 LS ASST CLRS W/SPL STPS 1000''S
FEI Number 1019632
Recalling Firm/
Manufacturer		 Ansell Healthcare Inc
1500 Industrial Road
Dothan AL 36303
For Additional Information ContactPhil Corke
732-345-5400
Manufacturer Reason
for Recall		The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
FDA Determined
Cause 2		Other
ActionRecall 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 in Commerceapproximately 40 million condoms
DistributionNationwide and Europe
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LTZ
510(K)s with Product Code = LTZ
510(K)s with Product Code = LTZ
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