Devices

Device Recall Diaphragm (contraceptive device)

Model / Serial
Lot 113367
Product Classification
Obstetrical and Gynecological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.
Product Description
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 || Intended for use in contraception.
Manufacturer
Cooper Surgical, Inc.
1 Event
- Recall of Device Recall Diaphragm (contraceptive device)

Manufacturer

Cooper Surgical, Inc.

Manufacturer Address
Cooper Surgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
Manufacturer Parent Company (2017)
The Cooper Companies, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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