Z-0287-2020 Class III Terminated
FDA device recall Z-0287-2020 was initiated by Biomedical Polymers, Inc. on September 18, 2019 and is designated Class III. Reason for recall: The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube. The recall status is terminated (terminated September 15, 2020). Affected quantity: 2,052,000.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- September 18, 2019
- Termination Date
- September 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,052,000
Product Description
Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
Reason for Recall
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
Distribution Pattern
US nationwide distribution.
Code Information
UPC: (01) 50885380116009 Lot numbers: 20180709A1C, 20180717A1C