Recall Z-3078-2017 ยท OJJ Burn Kit Without Drug
Certified Safety Mfg Inc
Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection
| Date | Jun 26, 2017 |
| Status | Terminated |
| Reason | Burn Sheet has possibility of being shredded. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified via email on approximately 06/26/2017. Instructions included removing any affected burn sheets from first aid kits in stock, notify customers to do the same, return the response form and make arrangements for replacement items if necessary. |
| Quantity | 214 kits total (1 burn pad per kit) |
| Distribution | US Nationwide Distribution in the states of KY, MD, NY, PA, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.