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