Recall Z-3078-2017— Certified Safety Mfg Inc
Class II · Terminated
Class II FDA medical device recall by Certified Safety Mfg Inc, initiated 2017-06-26, terminated 2020-11-03. FDA's recall record names no specific 510(k) clearance for this event. 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: Burn Sheet has possibility of being shredded..
- Recalling firm
- Certified Safety Mfg Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-26
- Terminated
- 2020-11-03
- Firm location
- Kansas City, MO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.