Agency classClass IIOur severity:High FDA (Devices)·Z-1477-2021·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (incomplete welds) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, and Tubing, as well as Medex LogiCal Kits. The affected components include the 1050 Stopcock Rotator (Model MX1431MR), 1050 Stopcock Left Rotator (Model MX1431MRL), and 700 PSI Stopcock with Rotator (Model MX4331R). These items are components for various cardiac kits, including pressure monitoring devices and interventional imaging devices.

The recall was initiated because these specific lots may have been manufactured with insufficient or incomplete welds. The affected units were distributed nationwide in the United States, including Puerto Rico, as well as in Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Healthcare facilities and consumers should stop using the affected stopcock rotators and contact Smiths Medical ASD Inc. for further instructions or a replacement. The recall number is Z-1477-2021.

The recalled product

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…
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Cardiac Components
Hazard: structural-defect
incomplete-weld
Affected units: 3,825

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

a. Model Number MX1431MR
Lot Numbers: 3995544 b. Model Number MX1431MRL
Lot Numbers: 3995545
4011838
4027758
4033501
4044959 c. Model Number MX4331R
Lot Numbers: 3971467
3987918

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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