FDA Recall
Terminated
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
Recall: Z-3078-2017
·
Initiated June 26, 2017
Recall
- Recall Number
- Z-3078-2017
- Event Number
- 77593
- Firm
- Certified Safety Mfg Inc
- FEI Number
- 1000158435
- Product Code
- OJJ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 26, 2017
- Terminated
- November 3, 2020
- Address
- 1400 Chestnut Ave, Kansas City, MO, 64127-2023
Description
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
Reason
Burn Sheet has possibility of being shredded.
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.
Distribution
US Nationwide Distribution in the states of KY, MD, NY, PA, VA
Quantity
214 kits total (1 burn pad per kit)