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Class 2 Device Recall Zero |
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Date Initiated by Firm |
January 14, 2013 |
Date Posted |
February 20, 2013 |
Recall Status1 |
Terminated 3 on August 06, 2015 |
Recall Number |
Z-0838-2013 |
Recall Event ID |
64246 |
510(K)Number |
K120394
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Product Classification |
Condom - Product Code HIS
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Product |
LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303.
A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). |
Code Information |
Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106. |
Recalling Firm/ Manufacturer |
Ansell Healthcare Products LLC 111 Wood Ave S Suite 210 Iselin NJ 08830-2700
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For Additional Information Contact |
Robert S. Mahler 732-345-2174
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Manufacturer Reason for Recall |
Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.
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FDA Determined Cause 2 |
Device Design |
Action |
Ansell HealthCare Product LLC sent an Recall letter dated January 14, 2013, via registered mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The recall notification informs customers about the problem with the affected product and provides instructions to the customers on how to handle affected product. Customers are asked to complete the Response Form and return via fax (1-800) 722-8155.
If you have further questions, please contact our Customer Service Department at 1-800-952-9916. |
Quantity in Commerce |
469,134 units |
Distribution |
.Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT. |
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 = HIS and Original Applicant = ANSELL HEATHCARE PRODUCTS LLC
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