Device product
Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.
Z-0286-2020
Product summary
- Event
- Event 83965
- Status
- Terminated
- Classification
- Class III
- Quantity
- 108,000
- Official record key
device-enforcement:Z-0286-2020
Official wording
Reason: 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.
Code information: UPC: (01) 20885380116008 Lot: 20180717A1
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
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.