Events

Recall of Device Recall UniCircuit (W Connector, Adaptor, Y piece)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

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
    52605
  • Event Risk Class
    Class 2
  • Event Number
    Z-1870-2009
  • Event Initiated Date
    2009-06-05
  • Event Date Posted
    2009-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83446
  • 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
    Breathing circuit - Product Code CAI
  • Reason
    Breathing circuit inner tube may separate from the rigid connectors under certain conditions. a separation of the inner tube from the connector may prevent adequate gas flow (o2, n2o and anesthetic agents) to the patient. a separation can also cause co2 re-breathing. this could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.
  • Action
    GE Healthcare sent consignees 6/5/09 an "Urgent Medical Device Correction" letter dated June 5, 2009. The letter was addressed to Health Care Administrator/Risk Manager; Chief of Anesthesia; Director of Clinical Engineering; Risk Manager. The letter described the Safety Issue, Affected Product Details, Safety Instructions (included "Recall Confirmation" form fax to 973-790-4150), Product Correction and Contact Information.

Device

Device Recall UniCircuit (W Connector, Adaptor, Y piece)
  • Model / Serial
    This correction pertains to Uni-Circuits from lot# 084812 and later, up to and including lot# 092210
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.
  • Product Description
    GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780, || M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662, || M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255 || M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628, || M1145406, M1147298, M1137811, M1152651, M1160275. pkg of 20 pcs, Latex Free. Breathing circuit for use with anesthesia machine or ventilator.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA