Smiths Medical is recalling the sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents (bacillus infantis and staphylococcus epidermidis) because of damage to the containers used to package the finished products. Use of these products in patients could result in infection and may require treatment with antibiotics. Serious or untreated infections could result in patient death.
The company initiated a voluntary recall on September 5, 2017. That recall covered several products, including some that are outside the scope of this notice. The Food & Drug Administration (FDA) is auditing the recall to ensure the company has notified all affected customers and that affected product has been returned. Based on the available information, the FDA is now classifying the action regarding the affected products as a Class I recall. The FDA identifies a Class I recall as the most serious type of recall, noting that “use of these devices may cause serious injuries or death”.
Click on the link below for information on which lots are involved and what to do if you are in possession of products affected by the recall.
Medical Device Recalls Medex Cardio-Pulmonary, doing business as Smiths Medical, Recalls Sterile S[3843]