Z-1829-2017Class III

Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079

Name: Z-1829-2017 Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079
Creator: Teleflex Medical
Published: 2017-03-29
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2017-03-29 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079 on 2017-03-29. FDA classified it as Class III and gives the reason as "Some of the individual unit packaging (pouches) may be missing the lot number an expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1829-2017
Classification: Class III
Status: Terminated
Initiated: 2017-03-29
Posted: 2017-04-04
Terminated: 2024-04-19
Recalling firm: Teleflex Medical
Product: Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
Root cause tag: packaging
FDA root cause: Incorrect or no expiration date
Action: Consignees were notified of the recall by letter on March 29, 2017. The letter requested that they check their inventory and immediately discontinue use and quarantine any product and to inspect on hand for missing lot numbers and expiration date. The letter included a reply form to be returned to Teleflex. A separate letter was sent to distributors requesting a sub-recall.
Quantity in commerce: 4760 eaches
Distribution: AL, AK, AZ AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, Canada and Costa Rica
Product codes and lots: 4799431

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1829-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1829-2017	Class III	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-15

Product code FMI

K091140Class IIEz-Mio Distal Tibia, Ez-Io Distal Tibia, Vidaport Intraosseous Infusion System, Ez-IoVidacare Corporation / cleared 2009-10-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)