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Recall Observatory FDA recall evidence

Device product

ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

Z-1636-2016

October 01, 2015

Class I

Product summary

Firm
Hummingbird Med
Event
Event 72350
Status
Terminated
Classification
Class I
Quantity
11500 units
Official record key
device-enforcement:Z-1636-2016

Official wording

Reason: Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the connection between the "Hummi" Y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.

Code information: Lot 15180, 15286, 15287, 15300, 15305

Distribution pattern: Distributed in the states of CA, KY, MD, GA, and IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the connection between the "Hummi" Y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.