Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0838-2013 — 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 tr

U.S. FDA — Device Enforcement · United States · 2013-01-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0838-2013
Date of alert
2013-01-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ansell Healthcare Products LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30070907205106
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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