Dear US Med-Equip Partner,
On April 27, 2020, USME received the attached Urgent Medical Device Recall regarding CME America BodyGuard Infusion Pumps. Please ensure that you read this notice immediately and in its entirety.
The current labeling for the BodyGuard Pump indicates a flow rate range of 0.1-1200mL/h, and an accuracy of +_5%. CMEA has recently completed internal testing to evaluate the flow rate accuracy across the labeled flow range. Results indicate that pumps may have a delivery inaccuracy of up to 13%. The pumps in question were pumps distributed beginning in March 2009.
Important: The BodyGuard Infusion Pump System is not indicated for the infusion of blood, blood products, or life-sustaining medications where under-delivery, or over-delivery could cause serious injury or death.
CME America has made the difficult business decision to suspend any further distribution of the BodyGuard Infusion Pump System until further notice and to remove all existing BodyGuard products from the U.S. Market.
The following CME America BodyGuard Infusion Pump System - including pumps, administration sets and accessories - products mentioned are affected by this recall:
Any CME America BodyGuard units from US Med-Equip (USME) are currently being taken out of service to prevent any adverse accidents. The units that are currently being rented and coming off of rent are also being labeled and taken out of service.
Per the recall, CME America will maintain the following continuity of care during the ongoing pandemic:
The manufacturer asks that you complete and return the Customer Response Form so that CME America may begin working on a phased withdrawal of all US pumps.
US Med-Equip carries a wide variety of infusion pumps and can assist with the replacement of recalled devices. Please feel free to contact US Med-Equip at (877) 677-7767 for assistance during this transition.
If you have an affected BodyGuard Infusion System unit from USME, please email firstname.lastname@example.org to place your report.
Please feel free to contact CME America Customer/Technical Support at 877-263-0111 (Toll-Free) between the hours of 8AM and 5PM MDT if you have any questions regarding this recall notification and the guidance provided.
Our Mission is to promote the healing process by providing smart solutions for our partners and the patients they serve.
We are committed to your patients as much as you are — it’s rooted in our daily actions — so we understand the importance of safely servicing recalls promptly.
For any further questions regarding equipment recalls, please reach out to email@example.com.
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