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Terminated

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

FDA Recall Z-1047-2016 · Posted None

Recalling FirmGi Supply
Recall StatusTerminated
Product CodeLRO
Date Initiated2016-01-28
Date Terminated2016-12-07
Product Quantity390 Kits

Reason for Recall

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.

Firm Action

The customers will be made aware of the defect, including pictures provided and are instructed to inspect the RP Bags in the kit prior to use. If the pinch clamp is missing, the customer is instructed to discard the RP Bag and use the sterile RP Bag replacements provided.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970187RUNYON LARGE VOLUME PARACENTESIS KITGi Supply · 1997-02-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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