EZ-IO Needle Set + Stabilizer Kit (2019-10-11)

Starting date:

October 11, 2019

Posting date:

October 25, 2019

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-71391

Last updated: 2019-10-25

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  Reason
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  Affected products

Affected Products

1. EZ-IO Needle + Stabilizer Kit
2. EZ-IO Needle Sets

Reason

The safety cap attached to needles within the EZ-IO Needle Sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. To date, there is only one reported needle stick. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle. As instructed in the IFU,  healthcare providers are reminded "do not recap needle sets or reconnect separated components. Use biohazard and sharps disposal precautions."

Affected products