Agency classClass IIOur severity:High FDA (Devices)·Z-1478-2021·Announced 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.

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 (insufficient 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 where injury has not yet been reported.

Plain-English summary

Smiths Medical ASD Inc. is recalling 275 units of Medex High Pressure Tubing, 72IN, Model Number MX152114, Lot Number 38801606. The recall also covers specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, and Medex LogiCal Kits. These items are components used in various cardiac kits, including pressure monitoring devices and interventional imaging devices.

The recall was initiated because the affected products may have been manufactured with insufficient or incomplete welds. Stopcocks and manifolds are used to control the direction of IV fluid flow, and the weld defects could compromise the integrity of these components.

The affected products were distributed in the United States (including Puerto Rico), Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan. Healthcare facilities and users should stop using the affected lots and contact Smiths Medical ASD Inc. for further instructions.

The recalled product

Product: HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Cardiac / IV Components
Hazard: structural-defect
weld-failure
Affected units: 275

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 (1)

Lot Numbers: 38801606

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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