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Recall Observatory FDA recall evidence

Device product

Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.

Z-0286-2020

September 18, 2019

Class III

Product summary

Firm
Biomedical Polymers, Inc.
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

    reason.no_named_rule · v1.0.0

    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.