[Recalled] Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ — Lack of sterility assurance: leaking containers which could lead to exposure to… | FDA 2017-09-05

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

• Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ — Class I
• Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ — Class I
• Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ — Class I
• Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ — Class I
• Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ — Class I
• Portex Unit Dose 15 ml Normal Saline ¿ — Class I

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.