CME America BodyGuard Infusion Pump System Recall

CME America BodyGuard Infusion Pump System Recall

Urgent Medical Device Recall for CME America BodyGuard Infusion Pump System

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.

Recalled Products

The following CME America BodyGuard Infusion Pump System - including pumps, administration sets and accessories - products mentioned are affected by this recall:

  • All models of BG 323, BG 121, BG 545*, BG CV545, BG 575*, BG CV575, and CM Express

US Med-Equip’s Solution

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:

  • Product service and repair activities through CME America and authorized service providers; however, if the infusion pump is beyond repair it is recommended that an alternative product be sourced.
  • A supply of infusion sets and accessories to support the BodyGuard infusion pumps remaining at your facility until the removal or disposal of pump(s) is complete.

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 qa@usmedequip.com to place your report.

CME America BodyGuard Contact Information

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.

The US Med-Equip Mission

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 qa@usmedequip.com.

US Med-Equip (USME) partners with top hospitals across the nation to provide the highest quality movable medical equipment for patients in their care. USME, an Inc. 5000 Fastest Growing company, supplies quality-certified equipment rented, sold, maintained and managed using the latest technology to help healthcare providers focus on their patients’ healing.