—#151511

Product

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

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K161183
Affected lot / code info: 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

Why it was recalled

Complaints of sheath separation, kinking, and/or tip damage during use.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: BARD PERIPHERAL VASCULAR, INC
Address: 1415 W 3rd St, Tempe, Arizona 85281-7634

Distribution

Distribution pattern: Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.

Timeline

Recall initiated: 2016-12-02
Posted by FDA: 2017-01-18
Terminated: 2017-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151511. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.