Agency classClass IIOur severity:Severe FDA (Devices)·Z-1481-2021·Announced 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.

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 recall is classified as FDA Class II and involves a structural defect (insufficient welds) in medical devices used for cardiac monitoring, which aligns with the rubric criteria for Severe severity involving structural defects or significant injury risks.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of Medex 10 IN Pressure Injector Lines with Rotators (1200psi), as well as other Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, Tubing, and LogiCal Kits. These items are components used in various cardiac kits, including pressure monitoring devices and interventional imaging devices.

The recall is being conducted because the affected products may have been manufactured with insufficient or incomplete welds. This defect could potentially compromise the structural integrity of the components during use.

The recall involves 500 units from Lot Number 3946994. 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 users should stop using the affected lots and contact Smiths Medical ASD Inc. for further instructions.

The recalled product

Product: Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Cardiac Monitoring Components
Hazard: structural-defect
weld-failure
Affected units: 500

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 Number 3946994

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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