Smiths Medical Recalls Intermed 550 ml Sterile Water Humidifiers
Smiths Medical is recalling Intermed 550 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of exposure to infectious agents due to a lack of sterility assurance, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling the Intermed 550 ml Sterile Water Humidifier with 5psi Adapter. The recall involves 16,104 units distributed worldwide, including the United States and several international countries. The specific lot numbers affected are Z588 and Z597.
The recall was initiated because the containers may leak, which could lead to a lack of sterility assurance. This defect poses a risk of exposure to infectious agents for patients using the devices.
Healthcare facilities and consumers should stop using the affected humidifiers immediately. Users should contact Smiths Medical for instructions on how to return or dispose of the devices.
The recalled product
- Product
- Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
- Category
- Medical Device — Humidifier
- Affected units
- 16,104
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 # 0552IMJ Lot Numbers: ¿Z588 and Z597
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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