Recall Z-1474-2021— Smiths Medical ASD Inc.

Name: FDA recall Z-1474-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-31

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2021-03-31, terminated 2023-03-20. It names one FDA 510(k) clearance: K961404. Product: Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.. Reason: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-31
Terminated: 2023-03-20
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K961404 — MX960 REUSABLE PRESSURE TRANSDUCERMedex, Inc.·cleared 1996-06-27

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

Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.

Reason for recall

Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

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