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U.S. Department of Health and Human Services

Class 2 Device Recall Sechrist Low Profile Wheeled Stretcher

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  Class 2 Device Recall Sechrist Low Profile Wheeled Stretcher see related information
Date Initiated by Firm June 01, 2015
Date Posted July 01, 2015
Recall Status1 Terminated 3 on October 20, 2015
Recall Number Z-1939-2015
Recall Event ID 71455
Product Classification Stretcher, wheeled - Product Code FPO
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Sechrist Industries Inc
4225 E La Palma Ave
Anaheim CA 92807-1815
For Additional Information Contact
714-579-8400
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 81 US Distribution
Distribution US Distribution and Internationally to Japan and Jordan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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