CLASS II ONGOING Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
Arrow Ez-io Intraosseous Vascular Access System recalled
Teleflex Medical is recalling Arrow Ez-io Intraosseous Vascular Access System Needle+Stabilizer Kit, distributed nationwide in the US. The recall was initiated on 8 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0688-2020
- FDA event ID
- 84054
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Oct 2019
- FDA classified
- 16 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 8 Oct 2019 | Recall initiated by company | |
| 16 Dec 2019 | Classified by FDA | +69 days |
| 25 Dec 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 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.
Where it was distributed
US nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All
Where was it sold?
US nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 84054This product is part of a recall event; the main page for the event is Arrow Ez-io Intraosseous Vascular Access System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Arrow Ez-io Intraosseous Vascular Access System recalled | Teleflex Medical | Sterility | Nationwide | |
| CLASS II | Arrow Ez-io Intraosseous Vascular Access System recalled | Teleflex Medical | Sterility | Nationwide |
More recalls from Teleflex Medical
All 235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |