Recall Z-0153-2022 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posteri
| Date | Aug 24, 2021 |
| Status | Terminated |
| Reason | Due to misbranded products shipped to customers. |
| Root cause | Process control |
| Action | On September 15, 2021, the firm, BD, sent out an "URGENT MEDICAL DEVICE CORRECTION" letter to their customers and Distributors via FedEx, informing them of the two products, first product or kit had missing component and the second product had extra component of the first product. The firm asked customers/Distributors to take the actions as: 1)Please check all inventory locations within your institution for the product listed in Table A and immediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local fa |
| Quantity | 360 devices |
| Distribution | U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve B Care Fusion, Sep 11, 2017 |