The Recall Desk
ModerateFDA (Devices)·Z-3078-2017·Announced 2017-09-06

Certified Safety Mfg Recalls Sterile Burn Sheets for Shredding Risk

Certified Safety Mfg Inc is recalling sterile burn sheets included in first aid kits because they may shred, potentially failing to protect patients from infection.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the product may cause temporary or medically reversible health consequences, or there is a remote probability of serious adverse health consequences. No injuries or illnesses are reported in the source text.

Plain-English summary

Certified Safety Mfg Inc is recalling sterile Burn Sheets (60" x 96") that are included in specific first aid kits. The recall is due to a possibility that the burn sheets may be shredded. The product is intended to provide a sterile environment to protect patients from infection.

The affected products are included in First Aid Kits (Part # K608-061 36M) distributed to Delmarva Power/ACE with logos, Certified Safety Manufacturing logo, and sold blank. The burn sheets are identified by Dukal Part # 7305, 30-01, and CSM Part # R505-091. Specific lot numbers for the burn pads are JT36112, JT09113, and JT17513.

A total of 214 kits were distributed nationwide in the states of Kentucky, Maryland, New York, Pennsylvania, and Virginia. Consumers and businesses should check their first aid kits for these specific part and lot numbers and stop using the affected burn sheets if found.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Burn Sheet: Dukal Part # 7305
  • 30-01
  • JT09113
  • JT17513.

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Certified Safety Mfg Inc

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