Halo One Thin-Walled Guiding Sheath recallZ-0968-2017 · Bard Peripheral Vascular, Inc · initiated Dec 2, 2016

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number

Z-0968-2017

Status

Terminated

Initiated by the company

Dec 2, 2016

Posted by the FDA

Jan 18, 2017

Recalling firm

Bard Peripheral Vascular, Inc

Quantity

101 units

Product code

DYB

FDA submissions

K161183

Distribution

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

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Halo One™ Thin-Walled Guiding Sheath HAL545

  Clearstream Technologies Limited · INTRODUCER, CATHETER
  1 recall2 reports

Product lines

• Halo One Thin-Walled Guiding SheathClearstream Technologies Limited · 27 models · 281 reports · 3 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 75875).

• Z-0969-2017 · Terminated
  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 she…
• Z-0970-2017 · Terminated
  Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introdu…