Z-1801-2015Class II

T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single...

Name: Z-1801-2015 T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single...
Creator: Vidacare Corporation
Published: 2015-05-12
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-05-12 / Terminated / root cause: design

FDA source

Vidacare Corporation began a recall of T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation on 2015-05-12. FDA classified it as Class II and gives the reason as "Potential breach in sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1801-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-12
Posted: 2015-06-15
Terminated: 2016-04-11
Recalling firm: Teleflex Medical
Product: T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Potential breach in sterility
Root cause tag: design
FDA root cause: Device Design
Action: Teleflex sent an Urgent Medical Recall Notification dated May 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter directed the customers to quarantine the affected product and return it to the manufacturer. If you have any further questions please call 1-866-246-6990.
Quantity in commerce: 2,104 boxes
Distribution: US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.
Product codes and lots: 3103376, 3103377, 3103378, 3524557, 3547157, 3693167, 3843307, 3868998, 3986753, 3991994, 3991995, 3999583, 4011996, 4023525, 4040723, 4040724

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1801-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1801-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15

Product code FMI

K120661Class IIThe T.a.l.o.n. Intraossous Infusion System by VidacreVidacare Corporation / cleared 2012-06-03

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)