Recall Z-2672-2014— Vidacare Corporation

Name: FDA recall Z-2672-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-31

Class II · Terminated

Class II FDA medical device recall by Vidacare Corporation, initiated 2014-03-31, terminated 2015-01-30. It names one FDA 510(k) clearance: K052408. Product: EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455. Reason: The voluntary recall is due to the needle set not meeting its specifications..

Recalling firm: Vidacare Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-03-31
Terminated: 2015-01-30
Firm location: San Antonio, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K052408 — EZ-IOVidacare Corporation·cleared 2005-11-17

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

EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

Reason for recall

The voluntary recall is due to the needle set not meeting its specifications.

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