Recall Z-0233-2018 ยท FPY Sheet, Burn
Dukal Corp.
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.
| Date | Jun 1, 2017 |
| Status | Terminated |
| Reason | Intact carton revealed presence of shredded burn sheets |
| Root cause | Nonconforming Material/Component |
| Action | 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 re |
| Quantity | 12095 cases/12 Packs per case/1 sheet |
| Distribution | Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.