Device 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.
Z-0690-2020
Product summary
- Firm
- Teleflex Medical
- Event
- Event 84054
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 526,000 total
- Official record key
device-enforcement:Z-0690-2020
Official wording
Reason: 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.
Code information: All
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
packaging may compromise the sterility