FDA recall Z-3078-2017

Certified Safety Mfg Inc · Class II · 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

Reason for recall

Burn Sheet has possibility of being shredded.

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-06-26
Report date
2017-09-06
Termination date
2020-11-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3078-2017