Agency classClass IOur severity:Critical FDA (Devices)·Z-0715-2019·Announced 2019-02-13

Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I' and the hazard as 'exposure to infectious agents,' which meets the rubric criteria for a Critical severity score (FDA Class I).

Plain-English summary

Smiths Medical Company, doing business as Medex Cardio-Pulmonary Inc., is recalling Portex 550 ml Sterile Water Humidifiers with 5psi adapters. The recall is due to a lack of sterility assurance caused by leaking containers, which could lead to exposure to infectious agents.

The affected product is Model # 0552C, Lot Number Z370. The recall covers 11,508 units distributed in Canada and the United States. In the US, distribution was nationwide, including Puerto Rico, and specific states such as Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, and Wisconsin. The product was also distributed in Austria, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

Consumers and healthcare facilities should stop using the affected humidifiers and contact Smiths Medical for instructions on return or replacement. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product: Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
Manufacturer: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Category: Medical Device — Respiratory Care
Hazard: infection
sterility-failure
Affected units: 11,508

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)

Model # 0552C Lot Number: ¿Z370

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 13 recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company 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 13 products in this recall →

Same manufacturer · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

See all →

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Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
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Same hazard · infection