Venous Hardshell Cardiotomy Reservoir (2019-09-12)

Starting date:

September 12, 2019

Posting date:

September 20, 2019

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-71027

Last updated: 2019-09-20

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  Reason
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  Affected products

Affected Products

Venous Hardshell Cardiotomy Reservoir

Reason

During verification testing of Adult/Small Adult VKMOs and VHK a potential impairment of the sterile packaging pouches of the accessories was detected, for products manufactured after March 4th 2019. Under unfavorable transport conditions, excessive movement of the device and its accessories in the carton can lead to stress points that could compromise the sterile barrier of the packaging pouches.

Affected products