Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560

FDA device recall Z-2446-2024 · posted 2024-08-02 · Open, Classified

Recall details

Recalling firm

Covidien

Reason for recall

Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway

Action taken

On 6/27/24, Medtronic started correction notice distribution to physicians, health care professionals, distributors, and users who were advised of the following: 1) Any single PB500 series ventilator should only be used for the 10-year labelled service life. If a patient requires ventilatory support for a longer period of time, cumulative sequential use of more than one PB500 series ventilator should be limited to 14 years. After 14 years of cumulative use, patients should be transitioned to an alternate device. 2) When approaching 14 years of cumulative use of a PB500 series ventilator, it is recommended that patients or their caregivers discuss transitioning to an alternate ventilator with the prescribing physician. 3) Review the correction notice information with all members of your staff who need to be aware of the contents of this communication. 4) Provide the correction notice to those who need to be aware within your organization or to any organization or person where the product has been transferred or distributed. 5) Medtronic has updated the labeling. Please refer to the User Manual and Clinician s Manual addendum 6) Complete and return the response form via email to rs.gmbmitgfca@medtronic.com If you have any questions regarding this communication, please contact your Medtronic Representative or Technical Service at 1-800- 255-6774.

Root cause

Device Design

Status

Open, Classified

Product code

CBK

Quantity affected

34,642

Distribution

US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR, TX, WI, PA, CO, MI, NM, RI, VA, DC, VT, NC, NH, WV, NV, IA. OUS: Argentina, Australia, Bangladesh, Belgium, Botswana, Bra

Date initiated

2024-06-24

Date posted

2024-08-02

Location

Carlsbad, CA

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