FDA Device recall Z-0689-2020
Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intr…
- FDA Device
- Class II
- ongoing
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intr… by Teleflex Medical, citing 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 is….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0689-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-08 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | US |
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 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
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.
Identifiers
| code_info | All |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0689-2020%22
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