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Firefly UV Disinfection Device

PURACATH MEDICAL, INC · Model 40406 · UDI-DI 00865349000308

KDJ Prescription
10
510(k) clearances
72,474
Adverse events (2,405 deaths)
61
Recalls
22
Facilities

Description

Battery powered Ultraviolet light disinfection device.

Recalls

DateFirmReason
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
2024-10-23Baxter Healthcare CorporationThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

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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.