Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter;
Product service and repair activities at CME America and Authorized Service Depots; and
Supply of infusion sets and accessories to support the infusion pumps remaining in the field.
The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.
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The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
BodyGuard 121
BodyGuard 323
BodyGuard 545*
BodyGuard 575*
BodyGuard 545 ColorVision
BodyGuard 575 ColorVision
CMExpress
*Note: These two pump models were inadvertently left out of the initial customer notification
CMEAmerica BodyGuard® Microset Infusion Set Recall Details
On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers.
To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers.
Affected products include:
CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.
Customer inquiries related to either recall, as well as adverse reaction/events experienced with the product should be addressed to CME America Support Center at 877-263-0111.
FDA MedWatch Reporting
