Events

Recall of Device Recall CADD(R) Medication Cassette with clamp and female Luer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD Inc..

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
    77555
  • Event Risk Class
    Class 2
  • Event Number
    Z-3071-2017
  • Event Initiated Date
    2017-06-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156494
  • 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
    Pump, infusion - Product Code FRN
  • Reason
    The medication cassette reservoir, part number 21-7002-24, with lot number 16x659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed incorrectly.
  • Action
    Consignees (may include distributors and hospitals) in Japan were notified the week of June 5, 2017. Recall letters were delivered by Smiths Medical, Japan sales representatives during the week of 06/19/2017. The consignees were directed to return any affected devices in their possession and receive replacements. Their Smiths Medical sales representative will collect the affected product and replacement product will be sent to them.

Device

Device Recall CADD(R) Medication Cassette with clamp and female Luer
  • Model / Serial
    lot number 16X659
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Japan, China, US
  • Product Description
    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Manufacturer Address
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA