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, risking needle stick injuries and sterility compromise.
What this means for you
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 sterility compromise) where specific injury counts are not reported in the source text, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Teleflex Medical is recalling 526,000 units of the Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit (Product Code 9001P-VC-005). The affected products were distributed nationwide in the United States. This device 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 the needles within the needle sets may become dislodged. If this occurs, the needle may be exposed and potentially protrude through the packaging. If the issue is not detected, the immediate risk is needle stick injury to the clinician or health care professional. Additionally, a puncture of the packaging may compromise the sterility of the needle.
Healthcare facilities and consumers should stop using the affected products immediately. Teleflex Medical is the recalling firm responsible for this action.
The recalled product
- 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
- Manufacturer
- Teleflex Medical
- 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)
- All
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.
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