BARD PERIPHERAL VASCULAR, INC: 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. Th

Is my product affected?

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 intro

• UPC 00801741111549

Check against the official notice below — it lists the full affected range.

What happened

Bard Peripheral Vascular, Inc. is recalling the Halo One 5F Introducer Sheath 45 cm (Product Code HAL545) due to complaints that the sheath may separate, kink, or become damaged at the tip during use. The device is designed to function as both a guiding sheath and introducer sheath for vascular procedures. A total of 101 units across multiple lot numbers were distributed nationwide to facilities in New York, Missouri, Florida, Kansas, Michigan, Texas, Nevada, Ohio, Maine, Washington, Louisiana, Arizona, Utah, and New Hampshire.

The recall record does not specify what remedy or action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Complaints of sheath separation, kinking, and/or tip damage during use.

Details from the source

Reason for recall: Complaints of sheath separation, kinking, and/or tip damage during use. Distribution: Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution. Quantity: 101 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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