# FDA recall Z-0690-2020

> **Teleflex Medical** · Class II · device recall initiated 2019-10-08.

## 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.

## 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.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-0690-2020
- **Recalling firm:** Teleflex Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-08
- **Report date:** 2019-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0690-2020

## Citation

> AI Analytics. FDA recall Z-0690-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0690-2020. Source: US FDA. Licensed CC0.

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