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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

OTC DRUG Nationwide Recall --Important Information About

Benzalkonium Chloride Antiseptic Wipes

 

Contact:
1-800-243-0741
productsupport@dukal.com.
Fax: 1-800-FDA-0178

 

FOR IMMEDIATE RELEASE - July 25, 2012 - Today, DUKAL Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for DUKAL by Jianerkang Medical Dressing Co. Benzalkonium chloride antiseptic wipes are sold separately over-the counter and in kits.
This recall is being initiated due to concerns about potential microbial contamination with Burkholderia cepacia. All customers are advised to discontinue use of products identified in this recall immediately as their use could lead to infections, some of which pose certain health risks in immune-suppressed patients. For average healthy people, the presence of Burkholderia cepacia on the swab is not likely to cause serious health risks. 
To date, there have been no reported incidents involving these products. In an abundance of caution, we are voluntarily recalling these products to prevent any such potential risk. All customers should dispose of the product. All distributors and kit packers, who include benzalkonium chloride swabs or antiseptic wipes as a component in their kits, should discontinue use of the product and initiate a sub-recall to their customers. All distributors and kit packers should return product in their inventories to DUKAL. These products were distributed nationwide to the wholesale and retail levels.
DUKAL is deeply committed to providing high quality, reliable products and issues this recall as a precaution to ensure consumer safety. DUKAL continues to work closely with FDA to ensure our products meet or exceed FDA requirements.

Instructions

This voluntary recall is for the following BZK product lot numbers:

 


Items

Description

Put Up

0204

Zee Antiseptic Swabs, Med 2ply

50/box, 36box/case

0271

Zee Antiseptic Swab, Med 2 ply

100/bx, 20bx/cs

854

Dukal BZK Swab Med. 2 ply NS

1/pch200/bx20bx/cs

02040

Zee Antiseptic Swab, Med 2 ply

50/box 36bx/cs

2633

Zee Antiseptic Swab, Med, 2ply

10/bx,10bx/bdl,6bdl/cs

854-1000

Dukal BZK Swab Med. 2 ply NS

1/pch1000/bx4bx/cs


 

Items

Lot No.

0204

JT14509

0204

JT15209

0204

JT20609

0204

JT20909

0204

JT23709

0204

JT27809

0204

JT32809

0204

JT00710

0204

JT15810

0204

JT18310

0204

JT18810

0204

JT23210

0204

JT25810

0204

JT27610

0204

JT31510

0204

JT35610

0204

JT35911

0204

JT04811

0204

JT05311

0204

JT11811

0204

JT15211

0204

JT15911

0204

JT18211

0204

JT21511-1

0204

JT26311

0204

JT30711

0204

JT22011-1

0204

JT01012

0204

JT04112

0204

JT06512

0204

JT07512

0271

JT14509

0271

JT15209

0271

JT21409

0271

JT20609

0271

JT22009

0271

JT00710

0271

JT18810

0271

JT23210

0271

JT35911

0271

JT05311

0271

JT11811

0271

JT26311

0271

JT01012

854

JT00610

854

JT14511

854

JT22011

854

JT30711

02040

JT14509

02040

JT15209

02040

JT20609

02040

JT15209

02040

JT23709

02040

JT27809

02040

JT00710

02040

JT18310

02040

JT18810

02040

JT23210

02040

JT27610

02040

JT31510

2633

JT14509

2633

JT15209

2633

JT21209

2633

JT27809

2633

JT12510

2633

JT15810

2633

JT18310

2633

JT11811

2633

JT13211

2633

JT15911

2633

JT35911

2633

JT01012

2633

JT30711

854-1000

JT34808

854-1000

JT08209

854-1000

JT15209

854-1000

JT32809

854-1000

JT00610

854-1000

JT27610

854-1000

JT05311

854-1000

JT08011

854-1000

JT18211

854-1000

JT22711-1

854-1000

JT26411

854-1000

JT01012

854-1000

JT01411

854-1000

JT14611

854-1000

JT29011

854-1000

JT01212

This voluntary recall is for BZK products still within product expiration date.
For more information, regarding this voluntary recall and whether to dispose of or return the product, the customer support team can be reached Monday to Friday from 8:30 am to 5:30 pm Eastern time at 800.243.0741. Emails may be sent to productsupport@dukal.com.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s Med Watch Adverse Events Program either online, by regular mail or by fax. 

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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