Device recall

Z-1047-2016: Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains…

FDA device recall · Class II · Gi Supply

Key facts

Recall number (Z-number) Z-1047-2016
Recall event 73151
Product Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04
Product code LRO
Recalling firm Gi Supply
Recall class Class II
Status Terminated
Termination date Dec 7, 2016
510(k) numbers K970187
FEI number 1000121355

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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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