Date Initiated by Firm |
November 25, 2002 |
Date Posted |
December 31, 2002 |
Recall Status1 |
Terminated 3 on October 15, 2003 |
Recall Number |
Z-0402-03 |
Recall Event ID |
25095 |
510(K)Number |
K981621 K971132 K000408
|
Product Classification |
Condom With Nonoxynol-9 - Product Code LTZ
|
Product |
LifeStyles 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 |
Recalling Firm/ Manufacturer |
Ansell Healthcare Inc 1500 Industrial Road Dothan AL 36303
|
For Additional Information Contact |
Phil 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 |
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 in Commerce |
approximately 40 million condoms |
Distribution |
Nationwide and Europe |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LTZ and Original Applicant = G. PREMJEE (USA), INC. 510(K)s with Product Code = LTZ and Original Applicant = SURETEX PROPHYLACTICS (INDIA) LTD. 510(K)s with Product Code = LTZ and Original Applicant = SURETEX PROPHYLACTICS LTD.
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