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U.S. Department of Health and Human Services

Class 2 Device Recall Burn Sheet, sterile 60 x 96

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  Class 2 Device Recall Burn Sheet, sterile 60 x 96 see related information
Date Initiated by Firm June 26, 2017
Create Date August 26, 2017
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-3078-2017
Recall Event ID 77593
Product Classification Burn kit without drug - Product Code OJJ
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
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.
Recalling Firm/
Manufacturer		 Certified Safety Mfg Inc
1400 Chestnut Ave
Kansas City MO 64127-2023
For Additional Information Contact
816-483-9090
Manufacturer Reason
for Recall		 Burn Sheet has possibility of being shredded.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 214 kits total (1 burn pad per kit)
Distribution US Nationwide Distribution in the states of KY, MD, NY, PA, VA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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