URGENT NOTICE MEDICAL DEVICE RECALL: Drive DeVilbiss Healthcare Car Charger Power Cord Accessory
April 18, 2025
Dear Portable Oxygen Concentrator Customer,
Purpose
The purpose of this Notice for Canadian Home Healthcare Inc. to inform you that Drive DeVilbiss Healthcare is voluntarily initiating a recall for the car charger cord provided as an accessory with your 125D series iGo®2 Portable Oxygen Concentrator (POC). The voluntary recall will apply to all Car charger cords provided with your iGo®2 POC system and replacement cords sold from January 1, 2023, through February 21, 2025. Table 1 and Figures 1, 2 and 3 below will help you identify the product being recalled.
Please discontinue use of the car charger cord and review the requested recall actions outlined below.
Reason for Voluntary Recall
The iGo®2 POC Car charger cord is a non-critical accessory to the iGo®2 POC. It allows the user to operate their iGo®2 POC from a DC power supply, such as the charging port in a vehicle. Under normal operating conditions, the car charger cord will power the unit, while concurrently charging the device’s internal battery. After receiving complaints related to overheating of the plug portion of the cable, an investigation determined the root cause was an assembly error; specifically, the fuse and the retention spring were installed in the reverse positions. It was confirmed that during some use situations, the adapter connection may become hot to the touch, and in some cases cause deformation of the plastic housing. The manufacturing assembly error has now been corrected.
Drive Devilbiss Healthcare is voluntarily implementing this recall of affected car charger cords. Please note that the car charger cord defect has no impact on the functioning of the iGo®2 Portable Oxygen Concentrator device or any other accessories.
Risk to Health
To date, there are no complaints of serious injury associated with this issue. During use, the adapter connection may become hot to the touch, and in a low number of cases, could cause a minor burn to the fingers or hand.
Actions To Be Taken By Our Customers
Please review the following methods to help identify affected car charger cords.
1. Identify if your car charger cord is being recalled by using the following identifiers:
a. Car charger cord model DV6X-619 Rev E with labeled lot number beginning with 2023-01-01 through 2024-12-31 (see Figure 1 below). Not all Rev E cords are recalled. Refer to 1c below to confirm if your Rev E unit is recalled.
Figure 1: “Rev E” label and lot number placement
b. If your product is not in the original plastic bag, affected car charger cords can also be identified by the serial number on the iGo®2 Portable Oxygen Concentrator unit (see Figure 2 below). To help identify affected car charger cords, check the serial number of your iGo®2 POC device against applicable serial numbers in Table 1.
Figure 2: Serial number placement on iGo®2 POC Device
c. If there is any doubt, you can easily inspect the car charger cord adapter by unscrewing the metal cap. (See Figure 3 for spring and fuse position.)
i. If the internal spring is next to the cap, this incorrect configuration is being recalled.
ii. If the fuse is next to the cap, this correct configuration is not recalled.
Figure 3: Inspecting the car charger cord adapter for spring or fuse position.
2. Discontinue use of the recalled car charger cord identified by the steps above. If you must use the car charger before it has been inspected and/or replaced, ensure the iGo®2 POC battery is fully charged before use and/or the flow setting is at or below 3 lpm.
3. Dispose of the car charger cord by either cutting the cord with wire-cutters or unscrewing the adapter cap. Canadian Home Healthcare/C.AIR will pick up and discard the parts when they deliver a replacement.
4. To obtain a replacement car charger cord, contact Canadian Home Healthcare/C.AIR via telephone at 1-800-268-5003 or info@canadianhomehealthcare.ca.
Canadian Home Healthcare/C.AIR Customer Service are available Monday through Friday, from 9:00 a.m. to 5:00 p.m. Eastern Time.
Table 1: Product identifiers subject to this recall
*Note: The iGo®2 POC is not being recalled; the iGo®2 identifiers are provided to assist in identifying defective car charger cords packaged with your portable oxygen concentrator.
Contact Information
Please contact us at 1-800-268-5003 or info@canadianhomehealthcare.ca with any further questions that you may have regarding this matter.
Canadian Home Healthcare appreciates your business and apologizes for the inconvenience and concern that this recall may cause you.
Sincerely,
Customer Service
Canadian Home Healthcare Inc.
URGENT: MEDICAL DEVICE RECALL Disposable Nasal Cannula
March 3, 2025
Dear Valued Customer:
Re: DISPOSABLE NASAL CANNULA
Catalogue Number: R-1701S
Please be advised Canadian Home Healthcare Inc. (CHH) is notifying you with respect to a recall involving a disposable Nasal Cannula from Canadian Hospital Specialties Ltd. (CHS Ltd.) which have been found to potentially have a partial blockage defect resulting in oxygen not being delivered correctly.
As a result of this situation, CHH is issuing this recall to address the functionality concerns of the Nasal Cannula. It was determined that the following Product Codes were affected.
CUSTOMER ACTIONS
Please take the following immediate actions:
1. Examine your cannula immediately to determine if you have any of the affected products listed above.
2. Discontinue use of any affected product.
3. Contact Canadian Home Healthcare at 1-800-268-5003 or info@canadianhomehealthcare.ca to arrange for an exchange of your affected product. Please do not discard unopened affected items.
Canadian Home Healthcare appreciates your business and apologizes for the inconvenience and concern that this recall may cause you.
Please contact us at 1-800-268-5003 or info@canadianhomehealthcare.ca with any further questions that you may have regarding this matter.
Sincerely,
Customer Service
Canadian Home Healthcare Inc.
URGENT: MEDICAL DEVICE RECALL Adult Nasal Cannula
October 18, 2024
Dear Valued Customer:
Re: ADULT NASAL CANNULA
Catalogue Number: R-1500S and R-1510
Please be advised Canadian Home Healthcare Inc. (CHH) is notifying you with respect to a recall involving the Adult Nasal Cannula from Canadian Hospital Specialties Ltd. (CHS Ltd.) which have been found to potentially have a partial blockage defect resulting in oxygen not being delivered correctly.
As a result of this situation, CHH is issuing this recall to address the functionality concerns of the Nasal Cannula. It was determined that the following Product Codes were affected.
P/N |
DESCRIPTION |
LOT NUMBER |
R-1500S |
Adult Nasal Cannula |
See included list for impacted lots |
R-1510 |
Adult Nasal Cannula |
CUSTOMER ACTIONS
Please take the following immediate actions:
1. Examine your cannula immediately to determine if you have any of the affected products.
2. Discontinue use of any affected product.
3. Contact Canadian Home Healthcare at 1-800-268-5003 or info@canadianhomehealthcare.ca to arrange for an exchange of your affected product. Please do not discard unopened affected items.
Canadian Home Healthcare appreciates your business and apologizes for the inconvenience and concern that this recall may cause you.
Please contact us at 1-800-268-5003 or info@canadianhomehealthcare.ca with any further questions that you may have regarding this matter.
Sincerely,
Customer Service
Canadian Home Healthcare Inc.
URGENT MEDICAL DEVICE RECALL
NASAL CANNULA ADULT
Impacted Product Codes & Lots
Product code |
Lot Numbers |
R-1500S |
040641 |
050141 |
|
042641 |
|
051041 |
|
050341 |
|
051741 |
|
052241 |
|
053141 |
|
060741 |
|
061541 |
|
062241 |
|
062841 |
|
070541 |
|
071341 |
|
071241 |
|
071944 |
|
072241 |
|
072641 |
|
080644 |
|
082441 |
|
091441 |
|
090741 |
|
083041 |
|
091246 |
|
092141 |
|
092841 |
|
042942 |
|
082142 |
|
100541 |
|
R-1510 |
052441 |
073041 |
|
082341 |
ResMed: Urgent Field Safety Notice for ResMed Masks With Magnets
On November 20, 2023 ResMed updated its existing contraindications and warnings for ResMed masks with magnets and potential magnetic interference with certain medical devices.
Masks with magnetic components are contraindicated for use by patients where they, or anyone in close physical contact while using the mask, have the following:
Active medical implants that interact with magnets or Metallic implants or objects containing ferromagnetic material.
For more information about the Field Safety Notice, click here.
For additional magnetic mask information from ResMed, click here.
If you believe you are affected and would like to be contacted with other mask options, please contact us at 1-800-268-5003.
Philips Respironics Mask Recall
Important information regarding the recall of certain Philips Respironics patient interface devices (face and nasal masks).
On September 15th, 2022 Philips Respironics announced that it is updating the existing contraindications and warnings of certain patient interface devices (face and nasal masks). The affected masks contain magnets which can potentially affect the functioning and/or induce the movement/dislocation of medical implants or medical devices that can be impacted by the magnetic fields.
For more information about the recall, click here.
Patient safety is always our concern. We are working with Philips Respironics daily to ensure adherence to and facilitation with the recall process. We are waiting to receive specific instructions from Philips on the replacement program.
For frequently asked questions, click here.
For the latest updates, click here.
If you have additional questions or concerns, please contact the dedicated Philips Patient Help Line at 1-877-387-3311.
Philips PAP Device Recall Update - June 2022
Dear client,
Philips provided the following update on June 28, 2022. To view the original notice click here.
SoClean 2 Recall Notice - Labelling Amendment
We are writing to notify you of a recent important change to the label and instructions for use applicable to the SoClean 2 device (Medical Device Licence No. 100197) in Canada.Philips PAP Device Recall Update - January 2022
Dear client,
Philips provided the following update on January 25, 2022. To view the original notice click here.
Dear Valued Customer,
As we enter 2022, we at Philips Respironics wish to provide you with an update on the status of the ongoing field safety notice announced in June 2021 for certain products in our CPAP, BiLevel PAP and mechanical ventilator portfolio.
As always, patient safety remains our top priority, and our intention is to ensure that as many patients as possible can continue safely with therapy. We are steadfast in our commitment to transparent communication, and we appreciate your cooperation and help in this continued partnership to address this issue with our patients across the globe.
We continue to engage with our patients, customers, competent authorities and clinicians, working together to accelerate the actions needed to complete this remediation in all affected markets.
Continued Commitment to Health and Safety Assessment
We are encouraged by the VOC test results to date for the first-generation DreamStation devices, which we published in December 2021.
The results indicate that VOCs do not exceed safe exposure thresholds specified in the applicable safety standards (e.g. ISO 18562). Using conservative health-protective exposure thresholds, the additional testing suggests no increased risk for adverse health effects in the general patient population nor the higher risk patient population as a result of VOC exposure. As we announced in December, it is important to note that the tested DreamStation devices were not exposed to ozone cleaning, as per the device instructions for use.
In accordance with the Philips Quality Management System, further health risk assessments are ongoing. Comprehensive particulate testing and analyses are expected to be completed in the second quarter of 2022, as testing protocols in compliance with the full extent of the relevant ISO standards (ISO 18562 and ISO 10993) for all affected product platforms require long lead times. We will continue to provide timely updates on findings from these assessments.
A summary of the test findings is available within the Philips Field Action Notification website.
In order to ensure maximum awareness and transparency to patients, we would kindly ask you to reinforce this finding as part of your regular interactions with patients.
We will continue to share details such as VOC analysis from the voluntary field action test and research program. Philips Respironics remains fully committed to this remediation and will continue to dedicate significant time and resources throughout 2022.
We would like to thank you for your support and patience in this very challenging time. Together we are making progress with our remediation program and continued testing. We sincerely appreciate your partnership and continued care.
Sincerely,
Eline de Graaf
SRC Business Market Leader
Update on Philips PAP Device Recall and Replacement
Latest Update on Philips Recall and PAP Device Replacement/Repair
Dear client,
We continue to keep you informed regarding the Philips Recall. Philips advised that affected devices may take up to twelve months to replace or repair.
The following is an excerpt taken from the Philips Registration team:
“What to expect next:
We regret that it may take some time to replace affected devices. The planned repair for the affected devices involves certain design changes, which in some markets may include review and/or authorization by the relevant regulatory agencies. We understand the impact of this issue and we sincerely regret this disruption.
For additional questions:
For more information and updates, please visit Philips.com/src-update where we will be updating answers to frequently asked questions (FAQ) as more information becomes available or call 1-877-907-7508 in the US and US territories or (0044) 20 8089 3822 outside the US.”
Philips Respironics PAP Device Recall
June 14th, 2021 Philips Respironics Company, makers of Positive Pressure Equipment (CPAP, APAP, BiPAP, and ventilators including non-invasive and invasive ventilation), announced the recall of some units due to possible health concerns related to disintegration of the sound abatement foam (polyester-based polyurethane (PE-PUR)) used inside the units to dampen the noise.COVID-19 Statement
The new Covid-19 regulations in Ontario will be effective Thursday, January 14th. Canadian Home Healthcare is still here to serve you.Our Response to COVID-19; A message from the CEO
What we are doing at Canadian Home Healthcare to prevent the spread of COVID-19 and continue to safely serve you.