Z-0969-2017 Class I Terminated
FDA device recall Z-0969-2017 was initiated by BARD PERIPHERAL VASCULAR, INC on Dec 2, 2016 and is designated Class I. Reason for recall: Complaints of sheath separation, kinking, and/or tip damage during use. The recall status is terminated (terminated Apr 5, 2017). Affected quantity: 101.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2017
- Initiation Date
- Dec 2, 2016
- Termination Date
- Apr 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 101
Product Description
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 percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
Reason for Recall
Complaints of sheath separation, kinking, and/or tip damage during use.
Distribution Pattern
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Code Information
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
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0969-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026