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Recall Observatory FDA recall evidence

Device product

Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

Z-0690-2020

October 08, 2019

Class II

Product summary

Firm
Teleflex Medical
Event
Event 84054
Status
Ongoing
Classification
Class II
Quantity
526,000 total
Official record key
device-enforcement:Z-0690-2020

Official wording

Reason: The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. 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.

Code information: All

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging may compromise the sterility