Recall Z-0689-2020— Teleflex Medical

Name: FDA recall Z-0689-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-08

Class II · Ongoing

Class II FDA medical device recall by Teleflex Medical, initiated 2019-10-08. It names one FDA 510(k) clearance: K141117. Product: Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-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.. 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..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Ongoing
Initiated: 2019-10-08
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K141117 — EZ-IO INTRAOSSEOUS INFUSION SYSTEMVidacare, LLC·cleared 2014-07-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.