Smith’s Medical is recalling over 2,900 emergency ventilators in the U.S. due to a fault linked to eight serious injuries, announced the Food and Drug Administration. This fault can lead to patients receiving incorrect ventilation levels or insufficient oxygen, and even partial or complete airway blockages. The ventilators in question, the Pneupac Parapac Plus 300 and 310 Ventilator Kits, are commonly used by healthcare professionals for oxygen delivery in various settings, including during transport and resuscitation efforts.
Reports indicate that the devices may intermittently provide continuous positive gas flow instead of the intended cycling, causing potential malfunction and compromising proper ventilation. Smiths Medical has advised customers to continue using the ventilators but to exercise heightened caution. Recommendations include continuous patient monitoring, independent checks of blood oxygenation and carbon dioxide levels, and ensuring access to alternative ventilation methods.
This recall adds to a series of regulatory actions against Smiths Medical, including previous Class I recalls involving other medical equipment. The company, acquired by ICU Medical in 2022, is addressing the issue while facing ongoing challenges inherited from its acquisition.