Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1939-2015Class II

Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H...

Sechrist Industries Inc / initiated 2015-06-01 / Terminated / root cause: design

Sechrist Industries Inc began a recall of 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 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1939-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sechrist Industries Inc
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.
Product code
FPO Stretcher, Wheeled
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.
Root cause tag
design
FDA root cause
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1939-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1939-2015Class IITerminatedVoluntary: Firm initiated