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DART-Reach

PULMODYNE INC · Model REACH700 · UDI-DI 00841470100322

CCT Prescription
1
510(k) clearances
24
Adverse events
6
Recalls
5
Facilities

Recalls

DateFirmReason
2018-03-19Teleflex Medical Europe LtdTeleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
2017-07-05Teleflex MedicalTeleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
2016-10-27Teleflex MedicalProduct Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
2009-03-05Sharn, Inc.Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
2009-03-05Sharn, Inc.Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
2009-03-05Sharn, Inc.Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.