Recall Z-0968-2017 ยท DYB Introducer, Catheter
BARD PERIPHERAL VASCULAR, INC
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 i
| Date | Jan 18, 2017 (initiated Dec 2, 2016) |
| Status | Terminated |
| Reason | Complaints of sheath separation, kinking, and/or tip damage during use. |
| Root cause | Device Design |
| Action | Bard sent an Urgent Medical Device Recall Notification letter dated December 2, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to find attached instructions detailing the steps they need to take regarding the product. Customers with questions were instructed to contact their Bard representative. Customers were provided the following instructions: 1. Records show that your facility has purchased product codes affected by this voluntary recall. Do not use or further distribute any affec |
| Quantity | 101 units |
| Distribution | Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161183 | Halo One Thin-Walled Guiding Sheath C.R. Bard, Inc., Jun 3, 2016 |