Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose 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 explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling Portex 350 ml Sterile Water Humidifiers with 5psi adapters. The recall involves 70,860 units of Model # 352 with lot numbers A214, A215, Z263, Z532, and Z555.
The recall is due to a lack of sterility assurance. The containers may leak, which could lead to exposure to infectious agents. This is classified as an FDA Class I recall.
The affected products were distributed nationwide in the United States, including Puerto Rico, and in several international countries including Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland. Users should stop using the affected units and contact the manufacturer for instructions.
The recalled product
- Product
- Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
- Category
- Medical Device — Humidifier
- Affected units
- 70,860
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)
- Model # 352 Lot Numbers: A214
- A215
- Z263
- Z532
- and Z555
Distribution
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.
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