MINNEAPOLIS, MN: Smiths Medical initiated a critical recall of its ParaPAC Plus ventilators Wednesday following reports of a potentially deadly malfunction.
The recall (fda.gov/medical-devices/medical-device-recalls/ventilator-recall-smiths-medical-removes-parapac-plus-ventilators-due-loosened-or-detached-patient)affects all PneuPAC paraPAC Plus P300 and P310 ventilators, which are widely used in emergencies and transport situations. The U.S. Food and Drug Administration (FDA) categorized this as a Class I recall, its most serious designation.
The company discovered that the patient outlet connector on these devices may loosen or detach, disrupting ventilation. This malfunction risks severe consequences, including respiratory arrest and death.
Smiths Medical confirmed one death and one injury linked to this issue.
The recall instructs healthcare providers to inspect all ParaPAC Plus ventilators immediately. Units with loose or movable connectors must cease operation pending repair by the manufacturer. Affected ventilators serve various critical functions, including emergency use at accident scenes, hospital transports, and CPR resuscitation support.
Smiths Medical urges users to maintain heightened vigilance, perform thorough pre-use checks, and ensure constant patient monitoring. The company advises keeping alternative ventilation methods, such as bag-mask ventilation, readily available.
Oliver Law Office, with its extensive experience in defective products litigation, stands ready to assist those impacted by this recall. Our team of dedicated attorneys can help evaluate potential claims, ensure proper compensation for damages, and advocate for improved safety standards in the medical device industry. Contact us today at 614-220-9100 or reach out online for a confidential consultation.