COMPASS HEALTH DVTREX-U Pressure Therapy System User Manual

COMPASS HEALTH DVTREX-U Pressure Therapy System

Specifications

FAQ

• Q: What is the reason for the recall?
• A: The recall is due to an error in the user manual suggesting that the REX Pressure Therapy System could be used to prevent DVT, which it is not designed or FDA-cleared to do.
• Q: What should customers do if they have the user manual?
• A: Customers should immediately replace the current user manual with the corrected version provided by Compass Health Brands and dispose of the old manual.
• Q: Who should be informed about this recall notice?
• A: Affected personnel including the Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager, and Field Technicians should be informed.
• Q: How can a replacement user manual be obtained?
• A: A replacement can be downloaded from the Compass Health Brands Product Recall page or ordered via phone or the reply form provided.

INSTRUCTION

Dear Valued Customer:
A voluntary Field Correction is being initiated by Compass Health Brands for the USER MANUAL for the REX (Recovery Exercise Trainer) Pressure Therapy System.
Reason for Field Correction: Compass Health Brands has recently identified an error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT).
This model of the compression system is not designed or FDA-cleared for this indication for use. To date, Compass Health Brands has received 0 customer complaints for this error, and 0 injuries.

HEALTH RISK:
If an end user uses this device to prevent DVT, the device may not be effective for this purpose which could result in user not receiving proper and effective treatment.

ACTIONS TO BE TAKEN BY THE CUSTOMER:
Immediately replace the current user manual included with the device with the attached, corrected version, and dispose of the current manual. Compass Health Brands will additionally mail you replacement user manuals in booklet format (which is the same format as the current user manual), if you prefer to use that as a replacement, instead.

REQUIRED ACTION

1. Ensure all affected personnel are fully informed of this notice. Forward this notice to your Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians.
2. The USER MANUAL for the REX (Recovery Exercise Trainer) Pressure Therapy System requires replacement.
3. Dealer/distributor must replace the user manual for any units still in your possession.
   • You may use the attached replacement user manual or visit https://compasshealthbrands.com/product-recall to download a replacement user manual.
   • Additionally, you may contact Compass Health Brands at 800-947-1728 or indicate on the attached reply form (Attachment A) to order a replacement user manual(s) in booklet format be mailed to you.
4. Dealer/distributor must complete and return the attached Distributor/Dealer Field Correction Response Form (Attachment A) to Compass Health Brands within fifteen (15) calendar days of receipt of this field correction notification confirming your acknowledgement. Send the completed form to Compass Health Brands via email at regulatory@compasshealthbrands.com. YOU MUST complete and return this form even if you do not have the affected product on hand.
5. Dealer/distributor must notify their customers that have received the REX (Recovery Exercise Trainer) Pressure Therapy System (using the attached Consumer Notification form) to alert them to this recall and the requirement to replace the USER MANUAL.

This voluntary Field Correction notification is being conducted with the knowledge of the United States Food and Drug Administration (FDA) in accordance with U.S. regulations. Any complaints and/or adverse events experienced with the use of this product must be reported promptly to Compass Health Brands Customer Support at 800-947-1728 Monday-Friday 8:00 am EST – 5:00 pm EST and/or to the FDA through its MedWatch program.
Compass Health Brands appreciates your immediate attention to this urgent matter – we apologize for the inconvenience this may cause.
Thank you,
Elizabeth Proctor
Director, Regulatory Compliance

ATTACHMENT

ATTACHMENT A – DISTRIBUTOR/DEALER FIELD CORRECTION REPLY FORM – RESPONSE REQUIRED
USER MANUAL for the REX (Recovery Exercise Trainer) Pressure Therapy System Model Number: DVTREX-U and DVTREX -L

March 2023
Complete and return this form to Compass Health Brands within fifteen (15) calendar days of receipt of this field correction notification confirming your acknowledgement. Send completed form to Compass Health Brands via email at regulatory@compasshealthbrands.com.

Please check ALL applicable boxes:

• I have received the letter and have notified my Regulatory Compliance Team.
• I have replaced the user manuals for all devices still in my possession.
• I have identified and notified all customers who purchased this product.

Check method of notification used:

• Mail__
• E-mail__
• Fax__
• Phone__

I have provided all customers who purchased this product with the updated USER MANUAL in electronic form.

How many User Manuals in booklet format would you like to have mailed to you?

How many devices have been sold to customers as of the date of this notification?____

CUSTOMER CONTACT INFORMATION (PLEASE PRINT CLEARLY):

• Name: ____
• Title: _____
• Address: ___
• City: _____
• State: _____
• Zip Code: __
• Telephone #: _____
• Email Address: ____
• Signature: ___
• Date: ___

A NEW DIRECTION IN HOME HEALTHCARE
6753 Engle Road, Middleburg Heights, Ohio 44130 | 800.947.1728 | compasshealthbrands.com

References

• Product Recall

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