Recall Z-3206-2024 ยท FCG Biopsy Needle
Bard Peripheral Vascular Inc
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.
| Date | Sep 20, 2024 (initiated Aug 2, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Packaging change control |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934370 | BIP BIOPSY NEEDLE MODIFICATION Bip USA, Inc., Mar 7, 1994 |