Devices

Device Recall CUSTOM FLEXIGUIDE NEEDLE, SERIES 15,

Model / Serial
Lot: K00136
Product Classification
Radiology Devices
Device Class
1
Implanted device?
No
Distribution
NV, AZ, CA, MI, UT, MO, CO, and OH
Product Description
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV || Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
Manufacturer
Alpha Omega Services Inc
1 Event
- Recall of Device Recall CUSTOM FLEXIGUIDE NEEDLE, SERIES 15,

Manufacturer

Alpha Omega Services Inc

Manufacturer Address
Alpha Omega Services Inc, 9156 Rose Street, Bellflower CA 90706-6420
Manufacturer Parent Company (2017)
Alpha-Omega Services 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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