Z-3078-2017Class II

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

Name: Z-3078-2017 Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified...
Creator: Certified Safety Mfg Inc
Published: 2017-06-26
License: https://open.fda.gov/license/

Certified Safety Mfg Inc / initiated 2017-06-26 / Terminated / root cause: manufacturing process

FDA source

Certified Safety Mfg Inc began a recall of 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... on 2017-06-26. FDA classified it as Class II and gives the reason as "Burn Sheet has possibility of being shredded". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3078-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-26
Posted: 2017-08-26
Terminated: 2020-11-03
Recalling firm: Certified Safety Mfg Inc
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
Product code: OJJ Burn Kit Without Drug
Reason for recall: Burn Sheet has possibility of being shredded.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3078-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3078-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-25

Product code OJJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)