Devices

Device Recall Breast Biopsy Kit

Model / Serial
LOT NO. 60812 EXPIRES: 11 /2012
Product Classification
Gastroenterology-Urology Devices
Device Class
1
Implanted device?
No
Distribution
USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Product Description
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. || Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Manufacturer
Custom Healthcare Systems, Inc.
1 Event
- Recall of Device Recall Breast Biopsy Kit

Manufacturer

Custom Healthcare Systems, Inc.

Manufacturer Address
Custom Healthcare Systems, Inc., 4205 Eubank Rd, Richmond VA 23231-4328
Manufacturer Parent Company (2017)
Custom Healthcare Systems 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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