Guidewire 70cm x 1mm (0.038 ) REF 5583705 recallZ-3062-2024 · Bard Peripheral Vascular Inc · initiated Jul 10, 2024

Why it was recalled

Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.

FDA root cause category: Under Investigation by firm

What the company is doing

On 08/01/2024, the firm sent an "URGENT: Medical Device Product Removal" letter via US mail and email to customers informing them that the firm has received multiple reports that guidewire may have been mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Customers are instructed to: 1. Discontinue use of product listed in the letter, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, ensure that these entities are contacted and informed of the recall. 3. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge your receipt of this notification and subsequently process any required credits. 4. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. 5. If products were purchased from a distributor, contact the distributor for further instructions and credit resolution. For questions/assistance contact: BD North American Regional Complaint Center for Product Complaints/Technical Questions at: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted Mon Fri 8:00am and 5:00pm CT, or Email: [email protected]. For recall related questions email [email protected]

Recall details

Recall number

Z-3062-2024

Status

Open, Classified

Initiated by the company

Jul 10, 2024

Posted by the FDA

Sep 6, 2024

Recalling firm

Bard Peripheral Vascular Inc

Quantity

625 units

Product code

DQX

FDA submissions

K770977

Distribution

Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.

Product description

Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.

Devices named in this recall

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

• Guidewire 5583705

  Bard Access Systems, Inc. · WIRE, GUIDE, CATHETER
  1 recall43 reports