FDA recall Z-0286-2020

Product

Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, 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

US nationwide distribution.

Key facts

Status

Terminated

Initiation date

2019-09-18

Report date

2019-11-13

Termination date

2020-09-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sterling, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0286-2020