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Adapter Set for flexible endoscope

CYGNUS MEDICAL L.L.C. · Model ASF2 · UDI-DI 00843356102246

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

Description

Adapter Set for flexible endoscope, includes 1 – BIOPSY PORT PLUG, 1 – SUCTION PORT PLUG, 1 – AIR/WATER PORT ADAPTOR, 1 – LL-MTF CONNECTOR, & 1 – TS- TUBING SOFT .25 ID X .375 OD X 2.5 LENGTH, Single Use - 1 Set. 120 Sets per Case

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.