Z-3078-2017 Class II Terminated
FDA device recall Z-3078-2017 was initiated by Certified Safety Mfg Inc on June 26, 2017 and is designated Class II. Reason for recall: Burn Sheet has possibility of being shredded. The recall status is terminated (terminated November 3, 2020). Affected quantity: 214 kits total (1 burn pad per kit).
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- June 26, 2017
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 214 kits total (1 burn pad per kit)
Product 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 for Recall
Burn Sheet has possibility of being shredded.
Distribution Pattern
US Nationwide Distribution in the states of KY, MD, NY, PA, VA
Code Information
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.