Events

Recall of Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

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

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
    29941
  • Event Risk Class
    Class 2
  • Event Number
    Z-1483-04
  • Event Initiated Date
    2004-07-28
  • Event Date Posted
    2004-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34811
  • 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
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) - Product Code DRT
  • Reason
    The trio monitor has latex feet. it is not labeled per 21 cfr801.437 to indicate that it contains latex.
  • Action
    On July 28, 2004, the firm sent out a Urgent Product Field Correction via FedEx to their customers. Enclosed with this letter was the replacement feet, an Instruction form and a field correction completion form.

Device

Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
  • Model / Serial
    Serial Numbers:    MC01475-D3; MC02325-K3; MC01476-D3; MC02120-I3; MC02017-I3; MC02004-I3; MC02011-I3; MC02018-I3; MC02047-I3; MC02039-I3; MC02196-I3; MC02279-K3; MC02295-K3; MC02298-K3; MC01478-D3; MC01491-D3; MC01496-D3; MC01865-G3; MC01455-D3; MC02281-K3; MC02237-I3; MC05179-C4; MC05180-C4; MC05191-C4; MC05194-C4; MC05206-C4; MC05218-C4; MC05223-C4; MC01497-D3; MC01452-D3; MC01473-D3; MC01490-D3; MC01493-D3; MC01861-G3; MC02354-K3; MC02293-K3; MC02303-K3; MC02316-K3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02292-K3; MC01487-D3; MC02285-K3; MC02309-K3; MC02313-K3; MC05082-C4; MC05107-C4; MC02306-K3; MC01862-G3; MC01918-H3; MC01479-D3; MC05183-C4; MC05189-C4; MC01474-D3; MC01477-D3; MC01450-D3; MC05072-C4; MC05075-C4; MC05083-C4; MC05089-C4; MC05090-C4; MC05105-C4; MC05178-C4; MC05195-C4; MC05209-C4; MC05210-C4; MC05212-C4; MC05213-C4; MC05214-C4; MC05215-C4; MC05217-C4; MC05224-C4; MC01448-D3; MC01449-D3; MC01464-D3; MC01481-D3; MC01495-D3; MC01859-G3; MC01867-G3; MC01890-H3; MC02348-K3; MC02359-K3; MC02363-K3; MC01453-D3; MC01860-G3; MC02199-I3; MC01460-D3; MC01806-G3; MC01954-H3; MC02135-I3; MC02136-I3; MC02146-I3; MC02168-I3; MC02171-I3; MC02278-K3; MC02280-K3; MC05172-C4; MC05173-C4; MC05174-C4; MC05181-C4; MC05184-C4; MC05188-C4; MC05190-C4; MC05201-C4; MC05203-C4; MC05208-C4; MC05219-C4; MC05222-C4; MC05225-C4; MC05227-C4; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3; MC05182-C4; MC05185-C4; MC05192-C4; MC05199-C4; MC01869-G3; MC02326-K3; MC02344-K3; MC02357-K3; MC02365-K3; MC01866-G3; MC01868-G3; MC01929-H3; MC01949-H3; MC02187-I3; MC02277-K3; MC01482-D3; MC01488-D3; MC02177-I3; MC02290-K3; MC02317-K3.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to hospitals and medical clinics nationwide.
  • Product Description
    Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
  • Manufacturer
    Datascope Corp

Manufacturer

Datascope Corp
  • Manufacturer Address
    Datascope Corp, 800 MacArthur Blvd, Mahwah NJ 07430-2001
  • Source
    USFDA