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Air Time

CYGNUS MEDICAL L.L.C. · Model HDF400Z · UDI-DI 00843356102703

JRJ
1
510(k) clearances
4
Adverse events
3
Recalls
24
Facilities

Description

AIRTIME™ HORIZONTAL DRYING, DIRECTIONAL FLOW TUBING SET. USED FOR DRYING COILED SCOPES. 4 TUBING PORTS

Recalls

DateFirmReason
2017-06-07Cenorin, LLCDryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
2017-06-07Cenorin, LLCDryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
2017-06-07Cenorin, LLCDryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

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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.