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WomanCare Global Single-Valve Aspirator

WOMANCARE GLOBAL TRADING, INC. · Model SVS-S10 · UDI-DI 00853615006352

HHI
10
510(k) clearances
46
Adverse events (3 deaths)
2
Recalls
20
Facilities

Description

The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, plunger, collar stop, o-ring, and removable valve liner. Aspirators are compatible with cannulae size 3-6mm. Aspirator is sterile, clean, and single use.

Recalls

DateFirmReason
2019-09-12Olympus Corporation of the AmericasBerkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
2016-05-19Richard Wolf Medical Instruments Corp.The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to crea

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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.