Agency classClass IIOur severity:Severe FDA (Devices)·Z-1474-2021·Announced 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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is Class II, and the defect involves structural integrity (incomplete welds) in medical devices used for pressure monitoring, which fits the 'Severe' criteria for structural defects.

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 was initiated because the affected products may have been manufactured with insufficient or incomplete welds. The recall covers 400 devices from Lot Number 4007165. Distribution was US nationwide including Puerto Rico, as well as Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Healthcare facilities and consumers should stop using the affected products and contact Smiths Medical ASD Inc. for further instructions.

The recalled product

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.
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Cardiac Monitoring
Hazard: structural-defect
incomplete-weld
Affected units: 400

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: 4007165

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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