BARD PERIPHERAL VASCULAR, INC: 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 a

Is my product affected?

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 req

• UPC 00801741129698

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 10 cm 5 pack due to complaints that the sheath may separate, kink, or sustain tip damage during use. The recall affects 101 units across four lot numbers that were distributed nationwide to facilities in New York, Missouri, Florida, Kansas, Michigan, Texas, Nevada, Ohio, Maine, Washington, Louisiana, Arizona, Utah, and New Hampshire.

The affected product code is HAL510F, with the following lot numbers involved: 50137866 (58 units), 50137924 (73 units), 50138170 (89 units), and 50138765 (27 units). The source document does not specify what actions affected consumers or facilities 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 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

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

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