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Recall Observatory FDA recall evidence

Device 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

Z-1047-2016

January 28, 2016

Class II

Product summary

Firm
Gi Supply
Event
Event 73151
Status
Terminated
Classification
Class II
Quantity
390 Kits
Official record key
device-enforcement:Z-1047-2016

Official wording

Reason: 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.

Code information: Lot #: 61442434 Expiration Date: 2018/04

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.