Teleflex Medical: 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.

Recall number

Z-0689-2020

Recalling firm

Teleflex Medical

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.

Status

Open, Classified

Initiated

2019-10-08

Posted

not on file

Terminated

not on file

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.

Root cause

Package design/selection

Action

Urgent Medical Device Correction notification letters dated 10/8/19 were sent to customers. Customer Action: Our records indicate you have received product that is subject to this correction. Place a copy of this notice with the product to ensure all users are aware of the need to perform this inspection. Removing the kits from the shelf box and placing them into bags (e.g. backpacks) could increase the potential for caps to become loose and product should be visually inspected again at point of use. Our records indicate that you have received products that are subject to this action. We are notifying our customers to take the following actions: 1. Immediately discontinue use and quarantine any products with the catalog number and lot number listed above. 2. Inspect affected products within your control to identify if the safety cap covers the needle, per Figure 1 below, this product is acceptable for use. a) If, after inspection, you identify codes/lots as defective, please: " dispose of such product locally; and " inform us of the affected codes/lots by faxing such information to 1-855-419-8507 or email to recalls@teleflex.com in order for your account to be credited. 3. If you have defective product, please complete the enclosed Acknowledgement Form and fax to [distributor fax number]. 4. If you have no affected stock, please complete the enclosed Acknowledgment Form and fax it to [distributor fax number]. This will allow us to document your receipt of this letter.

Quantity

526,000 total

Distribution

US nationwide distribution.

Lot, serial or model codes

All

510(k) numbers

["K141117"]

PMA numbers

not on file

Product code

FMI

Firm FEI

3005747797

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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