Events

Recall of Device Recall Sechrist Low Profile Wheeled Stretcher

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sechrist Industries 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
    71455
  • Event Risk Class
    Class 2
  • Event Number
    Z-1939-2015
  • Event Initiated Date
    2015-06-01
  • Event Date Posted
    2015-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137869
  • 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
    Stretcher, wheeled - Product Code FPO
  • Reason
    Sechrist industries is recalling the sechrist low profile wheeled stretcher because it may experience an unexpected incline angle during the height adjustment of the low profile wheeled stretcher when lifting the patient upward or when lowering the wheeled stretcher to a height at which the patient can be loaded/unloaded.
  • Action
    Seachrist sent an Urgent: Medical Device Correction letter dated June 1. 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate the Sechrist Low Profile Wheeled Stretcher identified in the attached serial number list (Attachment A) are affected by the field correction and are located at your facility. Within the following weeks, a Sechrist trained Field Service Technician will schedule a visit to your facility to install a Hydraulic Wheeled Stretcher Alignment kit which will greatly minimize the degree of the incline angle that can be experienced after it is installed. Customers are informed that within the following weeks, a Sechrist trained Field Service Technician will schedule a visit to their facility to install a Hydraulic Wheeled Stretcher Alignment kit which will greatly minimize the degree of the incline angle that can be experienced after it is installed. For further questions, please call: (714) 579-8318, or (714) 579-8311. We apologize for any disruption that this correction may cause. Sechrist is dedicated to ensuring the safety and quality of our products. If you have any questions about what to do, please contact us.

Device

Device Recall Sechrist Low Profile Wheeled Stretcher
  • Model / Serial
    Lot Code: 0086 0088 0024 0054 0056 0031 0040 0085 0046 0051 0121 0042 0032 0036 0021 0022 0015 0020 0065 0074 0066 0069 0007 0017 0005 0018 0004 0008 0062 0063 0038 0043 0033 0035 0037 0058 0071 0010 0011 0019 0049 0050 0055 0023 0039 0045 0059 0064 0028 0041 0044 0025 0001 0014 0068 0073 0057 0060 0027 0029 0030 0082 0083 0048 0070 0072 0034 0047 0009 0013 0080 0002 0081 0090 0091   Item No. 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-110-36H
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution and Internationally to Japan and Jordan.
  • Product Description
    Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H, || 21762-111-36H.
  • Manufacturer
    Sechrist Industries Inc

Manufacturer

Sechrist Industries Inc
  • Manufacturer Address
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807-1815
  • Manufacturer Parent Company (2017)
    Sechrist Industries Inc.
  • Source
    USFDA