Events

Recall of Device Recall Large Volume Paracentesis Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gi Supply.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73151
  • Event Risk Class
    Class 2
  • Event Number
    Z-1047-2016
  • Event Initiated Date
    2016-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143218
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    General surgery tray (kit) - Product Code LRO
  • 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.
  • 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.

Device

Device Recall Large Volume Paracentesis Kit
  • Model / Serial
    Lot #: 61442434 Expiration Date: 2018/04
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.
  • Product Description
    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
  • Manufacturer
    Gi Supply

Manufacturer

Gi Supply
  • Manufacturer Address
    Gi Supply, 200 Grandview Ave, Camp Hill PA 17011-1706
  • Manufacturer Parent Company (2017)
    Gi Supply Inc.
  • Source
    USFDA