Z-1642-2021 Class II Terminated
FDA device recall Z-1642-2021 was initiated by BIOPSYBELL S.R.L. on March 22, 2021 and is designated Class II. Reason for recall: Products labeled as sterile were distributed, but may not have been sterilized. The recall status is terminated (terminated February 17, 2026). Affected quantity: 1000 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 26, 2021
- Initiation Date
- March 22, 2021
- Termination Date
- February 17, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1000 units
Product Description
CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
Reason for Recall
Products labeled as sterile were distributed, but may not have been sterilized.
Distribution Pattern
US Nationwide distribution in the states MS and KY.
Code Information
LOT: 2001185, 2001243, 20051163