The Recall Desk
HighFDA (Drugs)·D-1675-2012·Announced 2012-09-26

Dukal Recalls ZEE Antiseptic Wipes Due to Microbial Contamination

Dukal Corp. is recalling ZEE Antiseptic Wipes due to contamination with Burkholderia cepacia. The affected products were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (Burkholderia cepacia) in a medical product, which fits the rubric criteria for 'High' severity (high-risk pathogens without reported illness).

Plain-English summary

Dukal Corp. is recalling ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter. The product is supplied in boxes of 10, 50, and 100 wipes and was distributed by ZEE MEDICAL, INC., Irvine, CA. The recall covers products shipped since July 02, 2009, with specific lot numbers listed in the agency's structured data.

The recall was initiated because of microbial contamination of the non-sterile product with Burkholderia cepacia. The distribution pattern for these products is nationwide.

Consumers should stop using the affected ZEE Antiseptic Wipes and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

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
Manufacturer
Dukal Corp.
Category
Medical Device — First Aid / Antiseptic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Dukal Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · microbial contamination

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