Device recall

Z-3078-2017: Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva…

FDA device recall · Class II · Certified Safety Mfg Inc

Key facts

Recall number (Z-number) Z-3078-2017
Recall event 77593
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
Recalling firm Certified Safety Mfg Inc
Recall class Class II
Status Terminated
Termination date Nov 3, 2020
FEI number 1000158435

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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