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.
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 injury 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 15mm Needle+Stabilizer Kit (Product Code 9018P-VC-005). The recall covers all lots and was distributed nationwide in the United States. The device is used to provide intraosseous vascular access in adult and pediatric patients when standard vascular access is difficult to obtain in emergent or urgent cases.
The recall was initiated because the safety cap attached to the needles within the needle sets may become dislodged. This defect can expose the needle and potentially cause it to protrude through the packaging. If the issue is not detected, there is an immediate risk of needle stick injury to clinicians or health care professionals. Additionally, a puncture of the packaging may compromise the sterility of the needle.
Health care facilities and users should stop using the affected devices and contact Teleflex Medical for instructions on how to return or dispose of the products. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-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.
See all 3 products in this recall →Related recalls
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