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

Class I - Dangerous

🏥 Medical Devices Recalled: December 2, 2016 BARD PERIPHERAL VASCULAR Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: BARD PERIPHERAL VASCULAR, INC
Reason for Recall:: Complaints of sheath separation, kinking, and/or tip damage during use.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0968-2017

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