Reported Jan 25, 2017 · Terminated
Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is…
Bard Peripheral Vascular, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BARD PERIPHERAL VASCULAR, INC · 1415 W 3rd St · Tempe, AZ · 85281-7634
Is this the product you have?
- Halo One 5F
- Introducer Sheath 90 cm Product CodeHAL590
- Product UsageThe 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
- Lot codes and dates
- 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
- Amount recalled
- 101
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Complaints of sheath separation, kinking, and/or tip damage during use.
Using this product could cause serious injury, illness or death — stop using it now.
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