Device recall

Z-2303-2014: Customed O.B. Pack convenience pack include multiple components: set up cover…

FDA device recall · Class I · Customed, Inc

Key facts

Recall number (Z-number) Z-2303-2014
Recall event 68536
Product Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with cuff, underbuttock drape…
Product code OKV
Recalling firm Customed, Inc
Recall class Class I
Status Terminated
Termination date Aug 14, 2017
FEI number 2648727

At a glance

  • None Linked 510(k)s
  • 100–999 Products in the same recall event
  • 10–99 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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