FDA-Device2016-03-16Class II
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
Gi Supply
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.
Sold states
Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.
Affected count
390 Kits
Manufactured in
200 Grandview Ave, N/A, Camp Hill, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1047-2016Don't want to check this manually?
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