Devices

Device Recall Halo One ThinWalled Guiding Sheath

Model / Serial
Product Code Lot Number UDI Number Quantity HAL590 50137570 (01)00801741111525(17)170331(10)50137570 95 HAL590 50137770 (01)00801741111525(17)170331(10)50137770 79 HAL590 50137979 (01)00801741111525(17)170331(10)50137979 95 HAL590 50138696 (01)00801741111525(17)170430(10)50138696 23
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Product Description
Halo One 5F Introducer Sheath 90 cm || Product Code: HAL590 || Product Usage: || The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
Manufacturer
BARD PERIPHERAL VASCULAR, INC
1 Event
- Recall of Device Recall Halo One ThinWalled Guiding Sheath

Manufacturer

BARD PERIPHERAL VASCULAR, INC

Manufacturer Address
BARD PERIPHERAL VASCULAR, INC, 1415 W 3rd St, Tempe AZ 85281-7634
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Halo One ThinWalled Guiding Sheath

Model / Serial
Product Code Lot Number UDI Number Quantity HAL545 50137556 (01)00801741111549(17)170331(10)50137556 95 HAL545 50137557 (01)00801741111549(17)170331(10)50137557 95 HAL545 50137598 (01)00801741111549(17)170331(10)50137598 95 HAL545 50137682 (01)00801741111549(17)170331(10)50137682 95 HAL545 50137723 (01)00801741111549(17)170331(10)50137723 95 HAL545 50137735 (01)00801741111549(17)170331(10)50137735 95 HAL545 50137875 (01)00801741111549(17)170331(10)50137875 95 HAL545 50137965 (01)00801741111549(17)170331(10)50137965 96 HAL545 50138274 (01)00801741111549(17)170331(10)50138274 95 HAL545 50138119 (01)00801741111549(17)170331(10)50138119 95 HAL545 50138118 (01)00801741111549(17)170331(10)50138118 95 HAL545 50138122 (01)00801741111549(17)170331(10)50138122 95 HAL545 50138273 (01)00801741111549(17)170331(10)50138273 95 HAL545 50138435 (01)00801741111549(17)170430(10)50138435 84 HAL545 50138437 (01)00801741111549(17)170430(10)50138437 95 HAL545 50138701 (01)00801741111549(17)170430(10)50138701 95 HAL545 50138439 (01)00801741111549(17)170430(10)50138439 95
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Product Description
Halo One 5F Introducer Sheath 45 cm || Product Code: HAL545 || The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular nor the coronary vasculature
Manufacturer
BARD PERIPHERAL VASCULAR, INC

Device Recall Halo One ThinWalled Guiding Sheath

Model / Serial
Product Code Lot Number UDI Number Quantity HAL510F 50137866 (01)00801741129698(17)170331(10)50137866 58 HAL510F 50137924 (01)00801741129698(17)170331(10)50137924 73 HAL510F 50138170 (01)00801741129698(17)170331(10)50138170 89 HAL510F 50138765 (01)00801741129698(17)170531(10)50138765 27
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Product Description
Halo One 5F Introducer Sheath 10 cm 5 pack || Product Code: HAL510F || Product Usage: || The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
Manufacturer
BARD PERIPHERAL VASCULAR, INC

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