FDAJanuary 28, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

gi supply

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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