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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94855

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 24, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Covidien

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2446-2024
Recall number
Z-2446-2024
Initiated
June 24, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Covidien
Quantity
34,642

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

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

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