Regional Block Needles 22G x 1.50in (2020-12-10)

Starting date:

December 10, 2020

Posting date:

December 22, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74617

Last updated:
2020-12-22

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  Reason
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  Affected products

Affected Products

Regional Block Needles 22G x 1.50in

Reason

Regional anesthesia needles instructions for use (IFU) (document# 10000354809 rev. 01) currently lists the following contraindication which was not approved nor reported to notified body (nsai) prior implementation:

"the risks associated with the use of this device may be increased due to patient physiological characteristics and clinical needs".

The initial contraindication(s) listed below were deleted/changed.

"These needles should not be used if there is:

• infection at the intended site of entrance
• allergy to the intended anesthetic agent
• evidence of a severe coagulation disorder
• sepsis
• abnormal anatomy that would preclude successful placement of the needle
• the patient is uncooperative or unable to be positioned adequately"

Affected products