FDA Recall Open, Classified

Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilator LATAM/4096600-04, Puritan Bennett 560 Ventilator EMEA/4096600-05, Puritan Bennett 560 Ventilator CAN ANZ/4096600-06, Puritan Bennett 540 Ventilator USA/4097100 Puritan Bennett 520 Ventilator/4098300, Puritan Bennett 520 Ventilator EU-DIV/4098300-01, Puritan Bennett 520 Ventilator Japan/4098300-02, Puritan Bennett 520 Ventilator APAC/4098300-03, Puritan Bennett 520 Ventilator EMEA/4098300-05, Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06, DL4096600 DL PB560 VENTILATOR/DL4096600, DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06, REFURBISHED PB540 VENTILATOR/DL4097100, Puritan Bennett 540 Ventilator Refurbished/DS4097100

Recall: Z-2446-2024 · Initiated June 24, 2024

Recall

Recall Number: Z-2446-2024
Event Number: 94855
Firm: Covidien
FEI Number: 2024500
Product Code: CBK
Status: Open, Classified
Root Cause: Device Design
Initiated: June 24, 2024
Posted: August 2, 2024
Address: 2101 Faraday Ave, Carlsbad, CA, 92008-7205

Description

Reason

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

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 [email protected] If you have any questions regarding this communication, please contact your Medtronic Representative or Technical Service at 1-800- 255-6774.

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, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Montenegro, Namibia, Nepal, New Zealand, Nigeria, Panama, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Viet Nam, South Africa, Austria, Kenya, Latvia, Lebanon, Mongolia, Nicaragua, Thailand, Tunisia, Algeria, Jordan, Libya, Malawi, Qatar, Pakistan, United Arab Emirates, Oman, Peru, Philippines, Bhutan, Iran - Islamic Republic Of, Bolivia, Kuwait, Egypt, Switzerland, Sudan, Norway, Korea - Republic Of, Bahrain, Ethiopia, Paraguay

Quantity

34,642