BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
Recall
- Recall Number
- Z-3206-2024
- Event Number
- 95174
- Firm
- Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438
- FEI Number
- 2020394
- Product Code
- FCG
- Status
- Open, Classified
- Root Cause
- Packaging change control
- Initiated
- August 2, 2024
- Posted
- September 20, 2024
Description
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
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.
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: [email protected]. Recall Related Questions - [email protected]
Worldwide - U.S. Nationwide distribution in the Puerto Rico and the countries of Canada, Pakistan, Peru, India, Malaysia, China, Brazil, Mexico, Japan, Chile, Australia.
60 (U.S.) and 5,160 (O.U.S.)