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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

Dukal Corp.: Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)

Agency Publication Date: September 17, 2012
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Affected Products

Product: ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA

Antiseptic wipes shipped since July 02, 2009. Lots: JT14509, JT15209, JT20609, JT20909, JT23709, JT27809, JT32809, JT00710, JT15810, JT18310, JT18810, JT23210, JT25810, JT27610, JT31510, JT35610, JT35911, JT04811, JT05311, JT11811, JT15211, JT15911, JT18211, JT18211, JT21511-1, JT26311, JT30711, JT22011-1, JT01012, JT04112, JT06512, JT07512, JT07710, JT14509, JT15209, JT21409, JT20609, JT33009, JT00710, JT18810, JT23210, JT35911, JT05311, JT11811, JT26311, JT01012, JT14509, JT15209, JT20609, JT15209, JT23709, JT27809, JT00710, JT00710, JT18310, JT18810, JT23210, JT23210, JT27610, JT31510, JT05809, JT14509, JT15209, JT21209, JT27809, JT12510, JT15810, JT18310, JT11811, JT13211, JT15911, JT35911, JT01012, JT30711

Product: Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031

Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 62320
Status: Resolved
Manufacturer: Dukal Corp.
Manufactured In: United States

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.