BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
FDA device recall Z-1634-2021 · posted 2021-05-19 · Terminated
Recall details
- Recalling firm
- BIOPSYBELL S.R.L.
- Reason for recall
- Products labeled as sterile were distributed, but may not have been sterilized.
- Action taken
- 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.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 50 units
- Distribution
- US Nationwide distribution in the states MS and KY.
- Date initiated
- 2021-03-22
- Date posted
- 2021-05-19
- Date terminated
- 2026-02-17
- Location
- Mirandola, Italy
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES (K130616) | Biopsybell S.R.L. | 2014-02-07 |