FDA recall Z-1644-2021
BIOPSYBELL S.R.L. · Class II · device
Product
11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
Reason for recall
Products labeled as sterile were distributed, but may not have been sterilized.
Distribution
US Nationwide distribution in the states MS and KY.
Key facts
- Status
- Terminated
- Initiation date
- 2021-03-22
- Report date
- 2021-05-26
- Termination date
- 2026-02-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mirandola, N/A, Italy
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2021