Recall Z-1637-2021— 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. FDA's recall record names no specific 510(k) clearance for this event. Product: 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD. 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
Product description
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
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.