Recall Z-1443-2014— Smiths Medical ASD, Inc.

Name: FDA recall Z-1443-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-17

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2014-03-17, terminated 2015-06-09. It names one FDA 510(k) clearance: K911383. Product: Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions. Reason: Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-17
Terminated: 2015-06-09
Firm location: Rockland, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K911383 — HOTLINE FLUID WARMERLevel 1 Technologies, Inc.·cleared 1991-10-17

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

Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

Reason for recall

Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.

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