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AESCULAP

Aesculap AG · Model EO016R · UDI-DI 04038653041305

HHM Prescription
10
510(k) clearances
92
Adverse events
4
Recalls
132
Facilities

Description

VALLEIX Uterine Probe, curved, 10" (250 mm), diam. 4 mm, graduated

Recalls

DateFirmReason
2024-07-31CooperSurgical, Inc.During the manufacturing process the devices were laser-marked with the incorrect part number.
2024-07-31CooperSurgical, Inc.During the manufacturing process the devices were laser-marked with the incorrect part number.
2019-12-11Centurion Medical Products CorporationIncomplete seals on the sterile package may compromise the sterility
2016-10-28Hologic, IncBreach in sterile barrier compromising product sterility

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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.