Events

Recall of Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor

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

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
    29892
  • Event Risk Class
    Class 1
  • Event Number
    Z-1414-04
  • Event Initiated Date
    2004-08-24
  • Event Date Posted
    2004-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34735
  • 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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
  • Reason
    The product is contaminated with burkholderia cepacia (formally known as pseudomonas cepacia), based on the texas health department analysis and also firm's analysis.
  • Action
    On 8/24/04 the firm issued letters via Fax to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm followed up with phone calls to all consignees completed by 8/25/04. The firm also issued a press release via Associated Press on 8/27/04.

Device

Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor
  • Model / Serial
    All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm has distributed the sensors to 1 researcher in Europe, and 68 to direct customers (medical facilities) and 112 Field Sales Reps. Currently, there are no finished goods at the manufacturing site. 655 cases of product were disposed of at the distribution facility due to product expiration. The firm estimates 442 cases (3,536 units) to be in distribution channels.
  • Product Description
    The probes involved have been part of the Nellcor¿ CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time.
  • Manufacturer
    Nellcor Puritan Bennett

Manufacturer

Nellcor Puritan Bennett
  • Manufacturer Address
    Nellcor Puritan Bennett, 4280 Hacienda Dr, Pleasanton CA 94588-2719
  • Source
    USFDA