The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1479-2021·Announced 2021-04-28

Smiths Medical Recalls High Pressure Rotators Due to Incomplete Welds

Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Rotators because they may have 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving potential structural defects in medical devices are categorized as Severe.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Rotators, including models MX496HP and MX497HP. These components are used in extravascular blood-pressure transducers and various cardiac kits, including pressure monitoring and interventional imaging devices.

The recall was initiated because the affected components may have been manufactured with insufficient or incomplete welds. This defect could compromise the integrity of the medical device components.

A total of 8,150 units were distributed nationwide in the United States, including Puerto Rico, as well as to 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 the manufacturer for further instructions.

The recalled product

Product
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Cardiac Monitoring Components
Hazard
Affected units
8,150

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 (5)

  • a. Model Number MX496HP
  • Lot Numbers: 3952480
  • 3974771 b. Model Number MX497HP
  • Lot Numbers: 3949391
  • 3971003

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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