Events

Recall of Device Recall Sequoia

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Chad Therapeutics 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
    31611
  • Event Risk Class
    Class 2
  • Event Number
    Z-1068-05
  • Event Initiated Date
    2005-03-25
  • Event Date Posted
    2005-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38236
  • 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
    oxygen conservers - Product Code BZD
  • Reason
    "shot size" below manufacturing specifications. risk of less than the specified quantity of oxygen delivered per pulse.
  • Action
    Firm recalled via email and letter on 3/25/2005. Firm is requesting returns of all units. Recall is on-going and is to the user or patient level.

Device

Device Recall Sequoia
  • Model / Serial
    For model #OM-302: Serial #21404202668-21404202680, 21404202682-21404202706, 21404202708-21404202709, 21404202711, 21404202713-21404202715, 21404202722, 21404202725, 21404202728, 21404202730, 21404202733-21404202735, 21404202738-21404202739, 21404202758, 21404202761, 21404202763; For model #OM-311: Serial #21404105027, 21404105030, 2140410503041, 21404105030, 21404105054-21404105055-21404105061, 21404105063-21404105066, 21404105068-21404105070, 21404105073-21404105074, 21404105076, 21404105078-21404105083, 21404105085-21404105086, 21404105089-21404105091, 21404105093-21404105094, 21404105096, 21404105100-21404105102, 21404105105, 21404105107-21404105113, 21404105115-21404105116, 21404105119, 21404105123-21404105124, 21404105127-21404105128, 21404105130-21404105131, 21404105133, 21404105137-21404105139, 21404105142-21404105144, 21404105151-21404105152, 21404105157, 21404105161, 21404105164-21404105168, 21404105170, 21404105172, 21404105178, 21404105180, 21404105182, 21404105185, 21404105194, 21404105201, 21404105204, 21404105206, 21404105209, 21404105211-21404105213, 21404105218, 21404105270-21404105271, 21404105273-21404105274, 21404105276-21404105277, 21404105279; For model #OM-312: Serial #21404301082-21404301159, 21404301161-21404301178
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to Canada, Sweden, Norway***
  • Product Description
    Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
  • Manufacturer
    Chad Therapeutics Inc

Manufacturer

Chad Therapeutics Inc
  • Manufacturer Address
    Chad Therapeutics Inc, 21622 Plummer St, Chatsworth CA 91311-4106
  • Source
    USFDA