Status
Terminated
Drug Enforcement D-1676-2012
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Classification
Class II
Report Date
September 26, 2012
Termination Date
June 21, 2013
Product Information
- Product description
- 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
- Product quantity
- —
- Reason for recall
- Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Dukal Corp.
- Address
-
2 Fleetwood Ct
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1676-2012
- Event ID
- 62320
- Recall initiation date
- June 14, 2012
- Center classification date
- September 17, 2012
- Code info
- Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711
- More code info
- —