Device recall

Z-2316-2014: LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD…

FDA device recall · Class I · Customed, Inc

Key facts

Recall number (Z-number) Z-2316-2014
Recall event 68536
Product LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT BEACON NON WOVEN (4) DRAPE UTILITY…
Product code FHI
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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