NEPHRAL ST 500 (2020-04-24)

Starting date:

April 24, 2020

Posting date:

May 8, 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-73031

Last updated: 2020-05-15

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  Reason
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  Affected products

Affected Products

1. NEPHRAL ST 500

Reason

Baxter is taking this action as a precautionary measure as these dialyzers were exposed to temperatures below 0 degrees C during shipment within Canada.  There may be a potential for internal blood leakages (IBLs) to occur during therapy with the use of the affected dialyzers.

Affected products