Z-1636-2016Class I

ABG-HM-1 Hummi Micro Draw Blood Transfer Device

Name: Z-1636-2016 ABG-HM-1 Hummi Micro Draw Blood Transfer Device
Creator: Hummingbird Med
Published: 2015-10-01
License: https://open.fda.gov/license/

Hummingbird Med / initiated 2015-10-01 / Terminated / root cause: design

FDA source

Hummingbird Med began a recall of ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters on 2015-10-01. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1636-2016
Classification: Class I
Status: Terminated
Initiated: 2015-10-01
Posted: 2016-05-20
Terminated: 2017-01-26
Recalling firm: Hummingbird Med
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.
Product code: KST System, Blood Collection, Vacuum-Assisted, Manual
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 10/01/15 the firm sent out customer notification letters. The letter states for the following actions to be taken: 1. Customers using the Hummi Micro Draw device are recommended not to use the identified lot. 2. A local distributor/sales representative will be contacting customers to arrange a return of the identified lot for credit and arrangement of replacement. 3. Replacement product should be available within 10 days of 10/30/15. 4. During the period of product unavailability customers might want to choose to temporarily to return their previous method for blood drawing. The firm requests a Reply Form be completed and returned via fax at 949-583-2775 or email to [email protected]. On 11/19/2015 the firm sent out a second notification letter involving additional recall lots. The firm provided the same instructions to customers as their previous notification; however stated replacement product should be available by mid December 2015.
Quantity in commerce: 11500 units
Distribution: Distributed in the states of CA, KY, MD, GA, and IL.
Product codes and lots: Lot 15180, 15286, 15287, 15300, 15305

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1636-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1636-2016	Class I	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-20

Product code KST

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)