Z-0968-2017 Class I Terminated
FDA device recall Z-0968-2017 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 units.
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 units
Product Description
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 introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular 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 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
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0968-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026