Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen

FDA device recall Z-3062-2024 · posted 2024-09-06 · Open, Classified

Recall details

Recalling firm

Bard Peripheral Vascular Inc

Reason for recall

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.

Action taken

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: productcomplaints@bd.com. For recall related questions email BDRC14@BD.COM

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DQX

Quantity affected

625 units

Distribution

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

Date initiated

2024-07-10

Date posted

2024-09-06

Location

Tempe, AZ

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