CME America BodyGuard Infusion Administration Sets (2020-06-16)

Starting date:

June 16, 2020

Posting date:

October 9, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74079

Last updated: 2020-10-09

• Reason
• Affected products

Affected Products

CME America BodyGuard Infusion Administration Sets

Reason

Testing on tube sets revealed that some infusion sets do not meet the ±5% delivery accuracy level of the system or the ±13% accuracy level identified in Health Canada Incident #201656; therefore, the use of the pump system could cause over-infusion or under-infusion of therapy and patient harm.

Affected products