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WomanCare Global 3mm Cannula
WOMANCARE GLOBAL TRADING, INC. · Model EB3 · UDI-DI 00853615006284
10
510(k) clearances
60
Adverse events (1 deaths)
3
Recalls
49
Facilities
Description
A sterile, tubular, semi-rigid, hand-held device, with a permanently-integrated winged base. Cannulae have two "whistle cut" type openings and do not show any sharp edges at the opening. Cannulae feature lines and numbers as indicators for measuring the depth of the uterus. Cannulae are color-coded using different color adapters. This is a single-use device, sealed into packaging and sterlized.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-16 | Olympus Corporation of the Americas | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events inv |
| 2014-10-27 | CooperSurgical, Inc. | The product has been identified to contain an incorrect curette type. |
| 2014-09-08 | Instrumed International, Inc. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a |
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