Health product recall

EXOGEN ULTRASOUND GEL (2020-12-14)

Starting date:
December 14, 2020
Posting date:
January 29, 2021
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-74865

Last updated: 2021-01-29

Affected Products 

EXOGEN ULTRASOUND GEL

Reason

We have learned that certain lots of Exogen ultrasound gel pump bottles used with the Exogen device may have microbial contamination. We have identified the affected lots and are requesting that patients discard gel bottles from those lots.

Affected products

EXOGEN ULTRASOUND GEL

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

M93771034420

Companies
Manufacturer
Bioventus LLC
4721 Emperor Blvd.
Suite 100
North Carolina
UNITED STATES