Device recall

Z-0258-2013: MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a…

FDA device recall · Class II · Kimberly-Clark Corporation

Key facts

Recall number (Z-number) Z-0258-2013
Recall event 63598
Product MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Product code FYA
Recalling firm Kimberly-Clark Corporation
Recall class Class II
Status Terminated
Termination date Jun 13, 2013
510(k) numbers K103406
FEI number 1000015879

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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