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Health product recall

Statlock Arterial Ultra Device

Starting date:
August 3, 2012
Posting date:
September 3, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15518

Recalled Products

A. Statlock Arterial Ultra Device

Reason

Certain lots of Statlock Arterial Stabilization Device were inadvertently packaged with the incorrect Instructions for Use (IFU) pamphlet. Each carton was packed with the IFU intended for Statlock Dialysis Stabilization Device instead of that for Statlock Arterial Ultra Device.

Affected products

A. Statlock Arterial Ultra Device

Lot or serial number

JUVCF204
JUUGF247
JUVJF331
JUVEF460
JUVHF303

Model or catalog number

ART0422

Companies
Manufacturer
Bard Access Systems Inc.