Recall Z-1639-2021— BIOPSYBELL S.R.L.

Name: FDA recall Z-1639-2021
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: 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. 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

10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK

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.