Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-3078-2017 · Posted None

Recall StatusTerminated
Product CodeOJJ
Date Initiated2017-06-26
Date Terminated2020-11-03
Product Quantity214 kits total (1 burn pad per kit)

Reason for Recall

Burn Sheet has possibility of being shredded.

Firm Action

Customers were notified via email on approximately 06/26/2017. Instructions included removing any affected burn sheets from first aid kits in stock, notify customers to do the same, return the response form and make arrangements for replacement items if necessary.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑