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Recall Observatory FDA recall evidence

Device product

Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.

Z-0287-2020

September 18, 2019

Class III

Product summary

Firm
Biomedical Polymers, Inc.
Event
Event 83965
Status
Terminated
Classification
Class III
Quantity
2,052,000
Official record key
device-enforcement:Z-0287-2020

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) 50885380116009 Lot numbers: 20180709A1C, 20180717A1C

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.