DiamondTemp Unidirectional Catheter (2021-02-26)

Starting date:

February 26, 2021

Posting date:

April 1, 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-75273

Last updated:
2021-04-01

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  Reason
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  Affected products

Affected Products 

1. DiamondTemp Unidirectional Catheter, Small Curve
2. DiamondTemp Unidirectional Catheter, Large Curve

Reason

This notification is to provide customers with important information regarding an error in the Instructions For Use (IFU) and package label for Diamondtemp Catheters relating to size and sheath compatibility. This notification provides corrections that address the potential risks associated with incorrect sheath size selection. Potential risks associated with sheath exchange, or use of inadequate sheath size, include blood stagnation, clots or air emboli.

Affected products