BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy Syste

FDA device recall Z-3206-2024 · posted 2024-09-20 · Open, Classified

Recall details

Recalling firm

Bard Peripheral Vascular Inc

Reason for recall

Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.

Action taken

On 08/28/2024, the firm sent an "URGENT: Medical Device Product Removal" Letter via FedEx and/or email to customers informing them that BD has identified through internal inspections, that the packaging of the Magnum Biopsy Needle may have been damaged by indentations unintentionally made during manufacture, potentially compromising the sterile barrier that may be hard to detect by the end user. 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 customers have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any required product replacement. 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 customers purchased this product from a distributor, contact their distributor for further instructions and credit resolution. Contact BD representative if assistance is needed with this process or contact the number below for further assistance: North American Regional Complaint Center for Recall questions, Product Complaints, Technical Questions - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com. Recall Related Questions - BDRC13@BD.COM

Root cause

Packaging change control

Status

Open, Classified

Product code

FCG

Quantity affected

60 (U.S.) and 5,160 (O.U.S.)

Distribution

Worldwide - U.S. Nationwide distribution in the Puerto Rico and the countries of Canada, Pakistan, Peru, India, Malaysia, China, Brazil, Mexico, Japan, Chile, Australia.

Date initiated

2024-08-02

Date posted

2024-09-20

Location

Tempe, AZ

Related 510(k) clearances