Agency classClass IIOur severity:High FDA (Devices)·Z-0690-2020·Announced 2019-12-25

Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, exposing needles and compromising sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (needle stick injury and compromised sterility) where specific injury or illness has not yet been reported, fitting the High severity criteria.

Plain-English summary

Teleflex Medical is recalling 526,000 units of the Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit (Product Code 9079P-VC-005). The product is used to provide 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.

The recall was initiated because the safety cap attached to needles within the needle sets may become dislodged. This can expose the needle and potentially cause it to protrude through the packaging. If this issue is not detected, there is an immediate risk of needle stick injury to the clinician or health care professional. Additionally, a puncture of the packaging may compromise the sterility of the needle.

The affected products were distributed nationwide in the United States. Health care professionals should stop using the affected devices and contact Teleflex Medical for further instructions.

The recalled product

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…
Manufacturer: Teleflex Medical
Category: Medical Device — Intraosseous Access
Hazard: needle-stick
sterility-compromise
Affected units: 526,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Teleflex Medical

See all →

Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Moderate
Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25

Same hazard · needle stick