Recall Z-1645-2021— BIOPSYBELL S.R.L.

Name: FDA recall Z-1645-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-22

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: 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB. 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

8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB

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.