Z-0689-2020Class II

Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 -

Name: Z-0689-2020 Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 -
Creator: Teleflex Medical
Published: 2019-10-08
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-10-08 / Open, Classified / root cause: packaging

FDA source

Teleflex Medical began a recall of Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular... on 2019-10-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0689-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-08
Posted: 2019-12-16
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.
Product code: FMI Needle, Hypodermic, Single Lumen
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.
Root cause tag: packaging
FDA 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 [email protected] 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 in commerce: 526,000 total
Distribution: US nationwide distribution.
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0689-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0688-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-25	2019-12-16
Z-0689-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-25	2019-12-16
Z-0690-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-25	2019-12-16

Product code FMI

K141117Class IIEz-Io Intraosseous Infusion SystemVidacare, LLC / cleared 2014-07-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)