Recall Z-1634-2021 ยท KNW Instrument, Biopsy
BIOPSYBELL S.R.L.
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
| Date | May 19, 2021 (initiated Mar 22, 2021) |
| Status | Terminated |
| Reason | Products labeled as sterile were distributed, but may not have been sterilized. |
| Root cause | Vendor change control |
| Action | The firm notified two consignees with the preliminary information by email on 03/22/2021 and followed with the official notice with the complete information on 04/08/2021 to all consignees. The letter requested that the consignee cease using the affected product and contact Biopsybell or a Biopsybell representative for product return/disposal and related replacement. Distributors were directed to identify those who received the product and notify them. |
| Quantity | 50 units |
| Distribution | US Nationwide distribution in the states MS and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130616 | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES Biopsybell S.R.L., Feb 7, 2014 |