Smiths Medical Recalls Intermed 350 ml Sterile Water Humidifiers
Smiths Medical is recalling Intermed 350 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves potential exposure to infectious agents, which is a significant health risk.
Plain-English summary
Smiths Medical Company is recalling Intermed 350 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 units were distributed worldwide, including the United States, Canada, and several countries in Europe and South America. Specific lot numbers involved in the recall are A457, A597, B157, B236, Z589, Z655, Z656, and Z661.
Healthcare facilities and consumers should stop using these devices immediately and contact Smiths Medical for instructions on return or replacement.
The recalled product
- Product
- Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
- Affected units
- 128,000
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 (8)
- Model # 0352IMJ Lot Numbers: ¿A457
- A597
- B157
- B236
- Z589
- Z655
- Z656
- and Z661
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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