Stimuplex Ultra 360 Insulated Echogenic Needle and Ultraplex 360 Non-Stimulating Echogenic Needle (2018-09-24)

Starting date:

September 24, 2018

Posting date:

October 19, 2018

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-67960

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  Reason
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  Affected products

Affected products

1. Stimuplex Ultra 360 Insulated Echogenic Needle
2. Ultraplex 360 Non-Stimulating Echogenic Needle

Reason

Manufacturer has identified the potential mix-up between 20 Ga x 4" Ultraplex 360° Needles and 20 Ga x 4" Stimuplex Ultra 360° Needles through investigations into reported customer complaints. The two (2) products identified above are both utilized for Peripheral Nerve Block, however, they are used with different techniques. Item 333634 is intended for visualization under ultrasound only, while 333648 is intended for nerve stimulation and may also be visualized under ultrasound.

Affected products