FDA Enforcement
Class II
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
·
Reported September 6, 2017
Enforcement
- Recall Number
- Z-3078-2017
- Event ID
- 77593
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Certified Safety Mfg Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- September 6, 2017
- Initiation Date
- June 26, 2017
- Classification Date
- August 25, 2017
- Termination Date
- November 3, 2020
- Address
- 1400 Chestnut Ave, N/A, Kansas City, MO, 64127-2023, United States
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.
Code Info
Burn Sheet: Dukal Part # 7305, 30-01, CSM Part # R505-091. First Aid Kit: CSM Part # K608-061 36M. Burn pad lot numbers: JT36112, JT09113, JT17513.
Distribution
US Nationwide Distribution in the states of KY, MD, NY, PA, VA
Quantity
214 kits total (1 burn pad per kit)