Agency classClass IOur severity:Critical FDA (Devices)·Z-0711-2019·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 FDA classified this recall as Class I, which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 57,336 units of Portex 550 ml Sterile Water Humidifiers with 5psi adapters. The recall involves Model # 552 with Lot Numbers A054, A089, A090, and Z262. The product was distributed nationwide in the United States, including Puerto Rico, as well as in Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

The recall is due to a lack of sterility assurance caused by leaking containers. This defect could lead to exposure to infectious agents. The FDA has classified this recall as Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

Healthcare facilities and consumers who have these specific lot numbers should stop using the product immediately. Users should contact Smiths Medical for instructions on how to return the product for a refund or replacement.

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 — Humidifier
Hazard: infection
leaking
Affected units: 57,336

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)

Model # 552 Lot Numbers: A054
A089
A090
and Z262

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
FDA (Devices) · 2019-02-13

Same hazard · infection