Recall Z-1634-2021— BIOPSYBELL S.R.L.
Class II · Terminated
Class II FDA medical device recall by BIOPSYBELL S.R.L., initiated 2021-03-22, terminated 2026-02-17. It names one FDA 510(k) clearance: K130616. Product: BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111. Reason: Products labeled as sterile were distributed, but may not have been sterilized..
- Recalling firm
- BIOPSYBELL S.R.L.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-22
- Terminated
- 2026-02-17
- Firm location
- Mirandola, N/A, Italy
510(k) clearances named in this recall
1 on FDA's record- K130616 — MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
Reason for recall
Products labeled as sterile were distributed, but may not have been sterilized.
Data sourced from openFDA. This site is unofficial and independent of the FDA.