Teleflex Medical: Medical Device Recall in 2019 - (Recall #: Z-0689-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 8, 2019

Date Posted: December 25, 2019

Recall Number: Z-0689-2020

Event ID: 84054

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.

Status: Ongoing

Product Quantity: 526,000 total

Code Information:

All

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated