The Recall Desk
HighFDA (Drugs)·D-1676-2012·Announced 2012-09-26

Dukal BZK Swabs Recalled for Burkholderia cepacia Contamination

Dukal Corporation is recalling BZK Swabs, First Aid Antiseptic, due to microbial contamination with Burkholderia cepacia. The recall covers specific lots shipped since July 2009.

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) without reported illness, which aligns with the rubric criteria for a High severity score.

Plain-English summary

Dukal Corporation is voluntarily recalling specific lots of BZK Swab, First Aid Antiseptic (Benzalkonium Chloride) 0.133% w/v. The recall is due to microbial contamination with Burkholderia cepacia in a non-sterile product. The affected items include Item 854-1000 (1000 swabs per box) and Item 854 (200 swabs per box), labeled with NDC 65517-00031.

The recall covers lots shipped since July 02, 2009. Specific lot numbers include JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT14511, JT22011, and JT30711. The distribution pattern is listed as nationwide.

Consumers should check their inventory for the specific lot numbers listed above. If the product matches the recalled lots, it should be returned to the point of purchase or disposed of according to local regulations. The source text does not report any specific illnesses or injuries associated with this contamination.

The recalled product

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
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 (15)

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

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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