FDA (Devices) recall action 87647

Smiths Medical ASD Inc. recalled 12 products on 2021-04-28

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2021-04-28
Critical: 0
Units: 35,960

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–12 of 12

HighFDA (Devices)··2021-04-28
Smiths Medical Recalls Stopcock Rotators Due to Incomplete Welds
Smiths Medical ASD Inc. is recalling specific stopcock rotator components used in cardiac kits due to insufficient or incomplete welds.
Product
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flo
Category
Distribution
1 state
HighFDA (Devices)··2021-04-28
Smiths Medical Recalls Left Heart Kits Due to Incomplete Welds
Smiths Medical ASD Inc. is recalling specific lots of Left Heart Kits and related components due to insufficient or incomplete welds.
Product
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Category
Distribution
1 state
HighFDA (Devices)··2021-04-28
Smiths Medical Recalls LogiCal Monitoring Sets Due to Incomplete Welds
Smiths Medical ASD Inc. is recalling specific lots of LogiCal Monitoring Sets and related components due to insufficient or incomplete welds.
Product
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Category
Distribution
1 state
SevereFDA (Devices)··2021-04-28
Smiths Medical Recalls Medex Pressure Injector Lines Due to Weld Defects
Smiths Medical ASD Inc. is recalling specific lots of Medex pressure injector lines and related components due to insufficient or incomplete welds.
Product
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Category
Distribution
1 state
HighFDA (Devices)··2021-04-28
Smiths Medical Recalls Medex High Pressure Tubing Due to Weld Defects
Smiths Medical ASD Inc. is recalling specific lots of Medex high pressure tubing and components due to insufficient or incomplete welds.
Product
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
Category
Distribution
1 state
HighFDA (Devices)··2021-04-28
Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits
Smiths Medical is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to potential manufacturing defects in welds.
Product
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
Category
Distribution
1 state
HighFDA (Devices)··2021-04-28
Smiths Medical Recalls Tubing Components Due to Incomplete Welds
Smiths Medical ASD Inc. is recalling specific lots of tubing components for blood-pressure transducers due to insufficient or incomplete welds.
Product
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
Category
Distribution
1 state
SevereFDA (Devices)··2021-04-28
Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.
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.
Category
Distribution
1 state
HighFDA (Devices)··2021-04-28
Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.
Product
Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
Category
Distribution
1 state
SevereFDA (Devices)··2021-04-28
Smiths Medical Recalls High Pressure Rotators Due to Incomplete Welds
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Rotators because they may have insufficient or incomplete welds.
Product
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
Category
Distribution
1 state
SevereFDA (Devices)··2021-04-28
Smiths Medical Recalls LogiCal Left Heart Kits Due to Weld Defects
Smiths Medical ASD Inc. is recalling specific lots of LogiCal Left Heart Kits and related components due to insufficient or incomplete welds.
Product
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Category
Distribution
1 state
SevereFDA (Devices)··2021-04-28
Smiths Medical Recalls Manifold Rotators Due to Incomplete Welds
Smiths Medical ASD Inc. is recalling specific lots of manifold rotators and related components because they may have insufficient or incomplete welds.
Product
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Mod
Category
Distribution
1 state