Class 1 Device Recall Halo One ThinWalled Guiding Sheath

• Date Initiated by Firm: December 02, 2016
• Date Posted: January 18, 2017
• Recall Status: Terminated on April 05, 2017
• Recall Number: Z-0969-2017
• Recall Event ID: 75875
• 510(K)Number: K161183
• Product Classification: Introducer, catheter - Product Code DYB
• Product: 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.
• 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
• Recalling Firm/ Manufacturer: BARD PERIPHERAL VASCULAR, INC; 1415 W 3rd St; Tempe AZ 85281-7634
• Manufacturer Reason for Recall: Complaints of sheath separation, kinking, and/or tip damage during use.
• FDA Determined 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 affected product. 2. Check all inventory locations within your institution for affected product code / lot number combination listed in the recall notice. If have further distributed any of the product code / lot numbers, immediately contact that location, advise them of the recall, forward instructions and have them return the affected product to BPV. 3. Remove any identified product from shelves. 4. If have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that intend to return. It is extremely important that this information is received . 6. Please call the firm's Recall Coordinator at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST). Once all information has been verified, the Recall Coordinator will issue you either a Return Authorization (XC) Number or Consignment Recall Number (XH) to facilitate the expedient return of the product. BPV will issue a credit for returned product. Email the completed Recall and Effectiveness Check Form to HaloOneRecall@crbard.com or fax it to BPV at 1-800-994-6772. If cannot email or FAX the form, please call the BPV recall coordinator at 1-8
• Quantity in Commerce: 101
• Distribution: Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DYB and Original Applicant = C.R. BARD, INC