Device recall

Z-2304-2014: Customed Laparoscopy convenience pack include multiple components: gowns, table…

FDA device recall · Class I · Customed, Inc

Key facts

Recall number (Z-number) Z-2304-2014
Recall event 68536
Product Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO sterilized surgical convenient…
Product code FDE
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
  • 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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