Occlutech Sizing Balloon (2018-08-31)

Starting date:

August 31, 2018

Posting date:

September 17, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67762

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  Reason
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  Affected products

Affected products

Occlutech Sizing Balloon

Reason

During the manufacturing step of "packaging and labeling" a mismatched Information For Use (IFU) was attached to some of the products from Lot B18007 (Article number REF 53SB355). Consequently, instead of the IFU for the Occlutech Sizing Balloon, the IFU for a completely different product has been attached to the product.

Affected products