Medline Sterile Water Humidifier Recalled for Leaking Containers
Smiths Medical is recalling Medline 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe).
Plain-English summary
Smiths Medical Company is recalling 16,380 units of Medline 300-350 ml Sterile Water Humidifiers with 5psi adapters. The recall is due to a lack of sterility assurance, as leaking containers could lead to exposure to infectious agents.
The affected product is Model # HCS00300, Lot Number Y576. The units were distributed worldwide, including nationwide in the United States and in Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
Healthcare facilities and consumers should stop using the affected humidifiers and contact Smiths Medical for instructions on return or replacement.
The recalled product
- Product
- Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
- Category
- Medical Device — Humidifier
- Affected units
- 16,380
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 # HCS00300 Lot Number: ¿Y576
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.
See all 13 products in this recall →Related recalls
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