CME BodyGuard Infusion Pump System (2020-03-06)

Starting date:

March 6, 2020

Posting date:

June 2, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73229

Last updated: 2020-06-02

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  Reason
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  Affected products

Affected Products

CME BodyGuard Infusion Pump System

Reason

The current labeling for the BodyGuard pump indicates a flow rate range of 0.1-1200ml/hr, 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%.

Affected products