Home / Recalls / Covidien / Z-2446-2024

Z-2446-2024 Class I Ongoing

Recalled by Covidien — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
August 14, 2024
Initiation Date
June 24, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,642

Product Description

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

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

Distribution Pattern

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

Code Information

REF/UDI-DI(GTIN): 4096600/10884521087798 4096600-01/10884521195998 4096600-02/10884521196001 4096600-03/10884521196018 4096600-04/10884521196025 4096600-05/10884521196032 4096600-06/10884521196377 4097100/4097100 4098300/10884521183636 4098300-01/10884521195943 4098300-02/4098300-02 4098300-03/10884521195967 4098300-05/10884521195981 4098300-06/10884521196384 DL4096600/10884521786509 DL4096600-06/10884521786516 DL4097100/DL4097100 DS4097100/DS4097100 All device serial numbers used before distribution of PB500 Series Ventilator User Manual and Clinician's Manual addendum, PT00196729 A, 2024-06-11

Other recalls by Covidien

  • Z-1557-2026 Class II — HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Pro (January 30, 2026)
  • Z-0486-2026 Class II — Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thi (September 25, 2025)
  • Z-0485-2026 Class II — Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thi (September 25, 2025)
  • Z-2151-2025 Class II — Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, (June 23, 2025)
  • Z-1915-2025 Class I — Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR (May 21, 2025)
  • Z-1390-2025 Class I — Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cann (February 26, 2025)
  • Z-0257-2025 Class II — Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-4 (September 19, 2024)
  • Z-2636-2024 Class I — McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only (July 9, 2024)
  • Z-2717-2024 Class II — Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly (July 9, 2024)
  • Z-2637-2024 Class I — McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only (July 9, 2024)