Events

Recall of Device Recall ThermiSense model 5700A5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Salter Laboratories, Division of Regulatory Affairs.

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
    57504
  • Event Risk Class
    Class 2
  • Event Number
    Z-1028-2011
  • Event Initiated Date
    2010-12-21
  • Event Date Posted
    2011-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96395
  • 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, breathing frequency - Product Code BZQ
  • Reason
    The incorrect length and connector were utilized in lot 110810 of the thermisense alice 5, making the product unusable as it will not interface with the sleep labs equipment.
  • Action
    Salter Laboratories, Inc. sent an URGENT PRODUCT RECALL LETTER dated December 20, 2010, to all affected customers. The letter identfied the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for this product and lot number. Contact Salter to arrange for the return of the product. Complete the attached reply form, confirming receipt of the letter, and fax it back to Salter Labs at 1-800-628-4690. For questions regarding this recall call 661-854-3166.

Device

Device Recall ThermiSense model 5700A5
  • Model / Serial
    Lot 110810
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH,
  • Product Description
    ThermiSense model 5700-A5 || The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study
  • Manufacturer
    Salter Laboratories, Division of Regulatory Affairs

Manufacturer

Salter Laboratories, Division of Regulatory Affairs
  • Manufacturer Address
    Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA