Recall Z-2248-2021 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
| Date | Jun 23, 2021 |
| Status | Open, Classified |
| Reason | Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. |
| Root cause | Packaging process control |
| Action | On 07/15/2021, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via FedEx to customers/distributors informing them that the firm has confirmed a complaint regarding an open packaging seal, breaking the sterile barrier. Customers are instructed to: 1. Please check all inventory locations within their institution for the product listed in Table A and immediately destroy all affected product remaining in their possession. The product should have the sterile barrier broken and destroyed per their local facilitys destruction process. 2. Share this notice with any users of the produ |
| Quantity | 560 devices |
| Distribution | U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan |
| 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 |