Z-1634-2021 Class II Terminated
FDA device recall Z-1634-2021 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: 50 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
- 50 units
Product Description
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
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
BATCH Numbers: 20061439