Events

Recall of Device Recall Mallinckrodt SatinSlip Intubating Stylet

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
    35879
  • Event Risk Class
    Class 2
  • Event Number
    Z-1431-06
  • Event Initiated Date
    2006-07-12
  • Event Date Posted
    2006-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47079
  • 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
    Stylet - Product Code BSR
  • Reason
    Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation.
  • Action
    The firm has issued notification letters via USPS certified mail with return receipt, requesting that the recipients who have further distributed the product forward a copy of that letter. The firm intends to contact non-responding companies beginning 30 days after the initial notification is sent.

Device

Device Recall Mallinckrodt SatinSlip Intubating Stylet
  • Model / Serial
    Model number 85863 (size 6 French), all lot codes beginning in 05 and 06
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product has been distributed to 454 consignees throughout the United States, Guam and Japan.
  • Product Description
    Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
  • Manufacturer
    Nellcor Puritan Bennett

Manufacturer

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