Recall Z-1829-2017— Teleflex Medical

Name: FDA recall Z-1829-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-29

Class III · Terminated

Class III FDA medical device recall by Teleflex Medical, initiated 2017-03-29, terminated 2024-04-19. It names one FDA 510(k) clearance: K091140. Product: Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.. Reason: Some of the individual unit packaging (pouches) may be missing the lot number an expiration date..

Recalling firm: Teleflex Medical
Classification: Class III
Status: Terminated
Initiated: 2017-03-29
Terminated: 2024-04-19
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K091140 — EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IOVidacare Corporation·cleared 2009-10-14

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

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

Reason for recall

Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

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