Dukal Corp. Recalls

FDA
3
Total Recalls
1
Agencies
Sep 2012
First Recall
Jul 2018
Latest Recall

Showing 1-3 of 3 recalls

FDA

BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

Intact carton revealed presence of shredded burn sheets

On May 30, 2017 Dukal sent an Urgent Product Recall notices and response forms to customers via UPS Overnight mail. On June 5, 2017 an amended recall notice was sent to customers to identify the correct the item number which is 7305. Customers were advised to do the following: 1. Email or fax the enclosed return card by June 30, 2017. 2. Immediately segregate your inventory of all Burn Sheet lots prefixed JT, Stop sales of such product and place in quarantine. 3. If you have further distributed this product, identify your customers, notify them of these lots being recalled and ask them to return the product for a full refund or replacement. 4. Product being recalled that is held in your inventory, as well as returns of that product from your customers, should be shipped to back to Dukal. Please contact Dukal service at 1-800-243-0741 for an RMA number. Upon receipt we will issue a full replacement or credit for product returned. All Product should be returned to the following Address: GEODIS 2385 Tremont Road Savannah, GA 31405 Tel. : +1 912 232 6125

FDA

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

Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)

FDA

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

Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)