You may have heard about the CME America BodyGuard infusion pump system recall, but are you certain how it affects you or what to do next? The Right Way Medical Team is here to support and guide you through the recall process.
Over the next three weeks, Right Way Medical is launching a three part series to supply you with the facts so you can make an educated plan to transition your patients to a safe, long term solution.
Does this impact me?
The CME America recall effects all new and refurbished BodyGuard and Express Infusion Pump Systems manufactured March 6, 2009 to November 26, 2019.
All serial numbers listed under the following model numbers are effected.
- BodyGuard 323
- BodyGuard 121
- BodyGuard 545 *
- BodyGuard CV545
- BodyGuard 575 *
- BodyGuard CV575
*BodyGuard 545 and BodyGuard 575 pump models were not included in the original recall. These pumps are included in the updated customer notification.
What do I need to know?
In January 2020, CMEA voluntary implemented a medical device recall due to inaccurate fluid delivery.
After additional internal testing by CME America, the BodyGuard pump was found to have a potential delivery inaccuracy of up to 13%, a total of 7% higher than the original labeling for the device.
On April 27, 2020, CME America notified all customers that they are suspending the distribution of the BodyGuard systems and will remove the infusion pumps from the U.S. market.
The pumps will continue to be supported for a one year period.
Do not panic; you have time to make the best long term decision for your patients. If you are currently treating a patient with any of the recalled devices, continue regular care until you can make an educated plan. Though we recommend you transition your patient off the device within the next six months, the device will be supported for one year.
Get an accurate count of how many recalled devices are being used in your facility and begin to make a list of the ideal date to transfer treatment for each device based on patient needs.
Over the upcoming weeks, the Right Way Medical Team will layout effective solutions to transfer patients off CME America BodyGuard and Express recalled pumps and products, and how to make the adjustment based on your patients timeline.
For more information, call the Right Way Team at 614.396.7721 or email RWM at firstname.lastname@example.org.
View the full release regarding FDA Recall Number: Z-1474-2020 and FDA Recall Number: Z-1442-2020 from CME America here.
About Right Way Medical:
Right Way Medical provides supply, logistic, technology, biomedical, and financing solutions to alternate site, long-term care, and specialty pharmacy healthcare providers through an innovative suite of products and services combined with the highest level of customer service. Founded in 2014, Right Way Medical has become a trusted name in the infusion industry, and focuses every day to continue to earn that trust and provide its customers with the ideal experience in acquiring healthcare related products and service.