Recall Z-2446-2024 ยท CBK Ventilator, Continuous, Facility Use
Covidien
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, Purit
| Date | Aug 2, 2024 (initiated Jun 24, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| 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 |
| Quantity | 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, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Czech Republic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070899 | PURITAN BENNETT LEGENDAIR XL2 Nellcor Puritan Bennett, Dec 13, 2007 |