Recall Z-1801-2015— Vidacare Corporation

Name: FDA recall Z-1801-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-12

Class II · Terminated

Class II FDA medical device recall by Vidacare Corporation, initiated 2015-05-12, terminated 2016-04-11. It names one FDA 510(k) clearance: K120661. 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. Reason: Potential breach in sterility.

Recalling firm: Vidacare Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-05-12
Terminated: 2016-04-11
Firm location: Shavano Park, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K120661 — THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACREVidacare Corporation·cleared 2012-06-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Potential breach in sterility

Data sourced from openFDA. This site is unofficial and independent of the FDA.