Medical device recalls Moderate risk

Certified Safety Mfg Inc recalls Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufa…

Recall date
June 26, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3078-2017
FDA classification
Class II
Brand / firm
Certified Safety Mfg Inc
Sold / distributed
US Nationwide Distribution in the states of KY, MD, NY, PA, VA

Why it was recalled

Burn Sheet has possibility of being shredded.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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