Percussionaire is recalling its Excessive Frequency Transport Phasitron Respiratory Circuit Kits because of a product defect that causes over-pressurization, in accordance with a medical machine recall discover from the US Meals and Drug Administration.
There are two elements of the Phasitron package that should be pressed collectively throughout manufacturing. If one half is angled incorrectly and pressed, the half can develop into deformed. This causes the constructive finish expiratory strain (PEEP) valve to be caught within the closed place. When the valve is caught, there isn’t a method to manually launch the valve.
The usage of the affected Phasitron kits could trigger severe opposed well being penalties, together with lung harm, low blood strain, collapsed lung, cardiac arrest, and dying. There have been three complaints concerning this machine problem, and one harm. There have been no experiences of dying.
The FDA has recognized this as a Class I recall, essentially the most severe sort of recall.
The Excessive Frequency Transport Phasitron Respiratory Circuit Package is used for steady air flow of sufferers. The package is meant for use with Percussionaire excessive frequency percussive air flow programs for both hospital or prehospital use the place emergency care is being offered. The package can be used for transport inside a hospital or outdoors a hospital.
- Product names: Excessive Frequency Transport Phasitron Respiratory Circuit Package (A50605-D)
- Product codes: See recall database entry
- Distribution dates: June 9, 2023, to Dec 1, 2023
- Gadgets recalled within the US: 2,145
- Date initiated by agency: Dec 12, 2023
On Dec 12, 2023, Percussionaire despatched all affected prospects an Pressing Subject Security Discover to distributors and well being care suppliers. The letter requested distributors to:
- Full and return the distributor acknowledgement type included together with the discover
- Ship Pressing Subject Security Discover containing Pre‐Use Guidelines to finish prospects
- Prioritize the return of affected tons in inventory
- Assist finish prospects returning affected merchandise
The letter requested well being care suppliers to:
- Full and return the acknowledgement type included together with discover
- Full Pre‐Test Guidelines (included with discover) previous to affected person use
- Prioritize the return of all impacted product
Clients within the US with questions on this recall ought to contact Percussionaire at 1-800-850-7205.
Well being care professionals and shoppers could report opposed reactions or high quality issues they skilled utilizing these gadgets to MedWatch: The FDA Security Data and Hostile Occasion Reporting Program utilizing a web-based type, common mail, or fax.