Device product

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

Z-3078-2017

June 26, 2017

Class II

Product summary

Firm: Certified Safety Mfg Inc
Event: Event 77593
Status: Terminated
Classification: Class II
Quantity: 214 kits total (1 burn pad per kit)
Official record key: device-enforcement:Z-3078-2017

Official wording

Reason: Burn Sheet has possibility of being shredded.

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.

Distribution pattern: US Nationwide Distribution in the states of KY, MD, NY, PA, VA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Burn Sheet has possibility of being shredded.