Agency classClass IIOur severity:High FDA (Devices)·Z-1475-2021·Announced 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.

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 is classified as FDA Class II and involves a structural defect (incomplete welds) in medical devices used for cardiac procedures, which poses a risk of harm without reported injuries.

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. These components are used in various cardiac kits, including pressure monitoring devices and interventional imaging devices.

The recall is being issued because these specific lots may have been manufactured with insufficient or incomplete welds. The affected products include the Angiographic Kit with MX123-3MR Manifold, Model Number MX1030, intended for use during angiography and other special procedures.

A total of 5,540 devices are included in this recall. The affected lots are 3979813, 3982717, 4016454, and 4024471. Distribution was US nationwide including Puerto Rico, as well as Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

The recalled product

Product: ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Cardiac / Interventional
Hazard: structural-defect
manufacturing-defect
Affected units: 5,540

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 (4)

Lot Numbers: 3979813
3982717
4016454
4024471

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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