BARD PERIPHERAL VASCULAR, INC: 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 intro

Is my product affected?

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 p

• UPC 00801741111525

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 90 cm (Product Code: HAL590), a thin-walled guiding sheath used in vascular procedures. The company received complaints that the sheaths separated, kinked, or sustained tip damage during use. The recall affects 101 units distributed nationwide across multiple states including New York, Florida, Texas, California, and others, spanning four different lot numbers with expiration dates in March and April 2017.

The recalled lot numbers are 50137570 (95 units), 50137770 (79 units), 50137979 (95 units), and 50138696 (23 units). The source document does not specify a remedy or instructions for affected consumers.

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 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

Source

Official record: FDA (Device enforcement) ↗

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

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