The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- BodyGuard Infusion Administration Sets- See full list of affected product types
- Lot Numbers: All
- Model or Catalog Numbers: All Administration Sets referenced in Appendix A of the most recent customer letter
- Manufacturing Dates: March 06, 2009 to November 26, 2019
- Distribution Dates: May 6, 2016 to May 11, 2020
- Devices Recalled in the U.S.: 4,877,792
- Date Initiated by Firm: June 16, 2020
BodyGuard 323 Infusion System Administrative Set
The BodyGuard Infusion Pump System delivers fluids and medications into a patient's body in controlled amounts. The pump provides fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system can be used in hospitals and home care settings.
Reason for Recall
CME America is updating their previously announced recall from April 27th because the BodyGuard Infusion System Administration Sets may have a slower than expected delivery of medication (under-infusion), faster than expected delivery of medication (over-infusion) or a delay in therapy. The reason for the infusion errors is not known.
Depending on the medication used in the affected infusion pump it may cause serious adverse health consequences including death. There have been 165 complaints regarding this device issue. There have been no injuries or deaths.
Who May be Affected
- Health care providers using the BodyGuard Infusion Pump System
- Home care providers using the BodyGuard Infusion Pump System
- Patients who may receive fluids or medications delivered by the BodyGuard Infusion Pump System
What to Do
On April 27th, 2020 CME sent a letter to customers telling them that the company is removing the BodyGuard Infusion Pumps, accessories, and infusion sets from the market. The letter asked customers to:
- Share this notice with appropriate personnel
- Identify and remove any remaining inventory of infusion sets, and discard.
- Complete the Customer Response Form, even if there are no affected products in inventory.
On June 16th, 2020, CME sent an updated letter to customers notifying them of additional testing that was performed on the infusion sets used with their BodyGuard Infusion Pump System. The additional testing noted some sets do not meet the ±5% delivery accuracy level of the system or the ±13% accuracy level identified in the earlier recall notification; therefore, the use of the pump system could cause over-infusion or under-infusion of therapy and patient harm.
The letter to customers includes tables clarifying which infusion sets are still able to be used, some of which have a new maximum flow rate, and which infusions sets cannot be used.
Customers who have questions about this recall may contact CME America’s Technical Support by phone at (877) 263-0111, Monday through Friday between 9:00 am and 5:00 pm Mountain Time.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
Affected Product Types
|BodyGuard BodySet||BodyGuard Microset with Needleless Adaptor|
|BodyGuard Microsets||BodyGuard Microset w/ Non-Vented Spike Connector|
|BodyGuard set with Female Luer||BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer|
|BodyGuard Microsets with Filter||Standard BodySet with Needleless Connectors|
|BodyGuard Microset with Filter and Manual Priming Valve||CMExpress Microbore Sets|
|BodyGuard Microset with Male Luer Connectors||CMExpress Needleless Y Site Microbore Set|