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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.