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

Recall date

January 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1047-2016

FDA classification

Class II

Brand / firm

Gi Supply

Sold / distributed

Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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