Recall Z-1689-2020 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
| Date | Mar 17, 2020 |
| Status | Terminated |
| Reason | Sterility compromised due to packaging pouches that may not be sealed properly |
| Root cause | Packaging process control |
| Action | Becton, Dickinson and Company (BD) issued notification on 3/17/20 stating reason for recall, health risk, and action to take: check all inventory locations within your institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, immediately contact that location, advise them of the recall, forward these instructions and have them complete the instructions within this recall notice. 3. Please remove any identified product from your shelves. 4. Destroy all identified product from the affected p |
| Quantity | 8,170 units (US: 420 and OUS: 7,750) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, IL, NJ, NY, OH, TN, VA and countries of AUSTRALIA, INDIA, JAPAN, MALAYSIA, NEW ZEALAND, PHILIPPINES and SINGAPORE. |
| 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 |