Reported Mar 16, 2016 · Terminated

Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most…

Gi Supply

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gi Supply · 200 Grandview Ave · Camp Hill, PA · 17011-1706

Is this the product you have?

  • 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 Date2018/04
Lot codes and dates
  • Lot #: 61442434
  • Expiration Date2018/04
Amount recalled
390 Kits

Where it was sold

Why it was recalled

Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 7, 2016 · Data as of Sep 19, 6:01 PM UTC

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