Z-0968-2017Class I

Halo One 5F Introducer Sheath 45 cm

Name: Z-0968-2017 Halo One 5F Introducer Sheath 45 cm
Creator: Bard Peripheral Vascular, Inc
Published: 2016-12-02
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2016-12-02 / Terminated / root cause: design

FDA source

BARD PERIPHERAL VASCULAR, INC began a recall of 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... on 2016-12-02. FDA classified it as Class I and gives the reason as "Complaints of sheath separation, kinking, and/or tip damage during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0968-2017
Classification: Class I
Status: Terminated
Initiated: 2016-12-02
Posted: 2017-01-18
Terminated: 2017-04-05
Recalling firm: Bard Peripheral Vascular Inc
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
Product code: DYB Introducer, Catheter
Reason for recall: Complaints of sheath separation, kinking, and/or tip damage during use.
Root cause tag: design
FDA 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 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 [email protected] 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 units
Distribution: Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0968-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0968-2017	Class I	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18
Z-0969-2017	Class I	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18
Z-0970-2017	Class I	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18

Product code DYB

K161183Class IIHalo One Thin-Walled Guiding SheathC.R. Bard, Inc. / cleared 2016-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)