Laparotomy Sponge (2019-02-27)

Starting date:

February 27, 2019

Posting date:

March 22, 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-69384

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  Reason
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  Affected products

Affected Products

Laparotomy Sponge

Reason

This recall has been initiated in response to concerns of potential sterility assurance level other than 10-6. In addition to the normal risk of infection that any procedure carries, deviation in the sterility assurance level may attribute to potential increase in patient infection risk.

Affected products