Device recall

Z-2315-2014: LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I)…

FDA device recall · Class I · Customed, Inc

Key facts

Recall number (Z-number) Z-2315-2014
Recall event 68536
Product LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20" (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I) TABLE COVER REINFORCED 50" X 90" (…
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

Browse all FDA device recalls (products)