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WomanCare Global Miscarriage Management Kit
WOMANCARE GLOBAL TRADING, INC. · Model MMK-SU · UDI-DI 00853615006291
10
510(k) clearances
46
Adverse events (3 deaths)
2
Recalls
20
Facilities
Description
Each kit contains one Ipas Double-Valve Aspirator, 4 Ipas EasyGrip® Cannulae: 6mm, 7mm, 8mm, and 9mm, 3 Denniston Dilators: 5/6mm, 7/8mm, and 9/10mm.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-12 | Olympus Corporation of the Americas | Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate |
| 2016-05-19 | Richard 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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