Z-1908-2016Class I

ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral...

Name: Z-1908-2016 ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral...
Creator: Hummingbird Med
Published: 2015-03-11
License: https://open.fda.gov/license/

Hummingbird Med / initiated 2015-03-11 / Terminated / root cause: manufacturing process

FDA source

Hummingbird Med began a recall of ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters on 2015-03-11. FDA classified it as Class I and gives the reason as "Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1908-2016
Classification: Class I
Status: Terminated
Initiated: 2015-03-11
Posted: 2016-07-05
Terminated: 2017-02-07
Recalling firm: Hummingbird Med
Product: ABG-HM-1 Hummi Micro Draw Blood Transfer Device; 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 the Hummi Micro Draw because of insertion difficulties.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Hummingbird Med Devices, Inc., sent a "Safety Alert" on March 3, 2015 and Addendum on March 11, 2015, to all affected customers. The notification sent on March 3, 2015, instructed customers that: 1) the Hummi Micro device is not recommended to be used with the Baxter Interlink device with the Hummi Micro draw blood transfer device as the Interlink T Connector septum may be damaged. 2) the use of Nexus Medical Micro-T Split Septum T Connector NMT8046 with all uses of the Hummi Micro Draw Blood Transfer device. The connector has been tested and validated for use in combination with the Ameritus Medical's Hummi Micro-Draw Blood Transfer Device. 3) Distributors of the Hummi Micro Draw Device contact and inform all Hummi Micro-Draw Blood Transfer Device users to recommend change to the Nexus Split Septum Micro-T Connector NMT8046 for all uses with the Hummi Micro Draw device. Inservice materials and training on proper Hummi Micro Draw device blunt cannula insertion into the connector's septum will be provided. 4) Distributors complete the attached form indicating hospitals and date contacted, name, and contact information of responsible person and resulting outcome. and 5) Scan and email the attached form to: [email protected] or fax to: 1-949-583-2775. On March 11, 2015, the firm sent out a second email to their distributor to inform customers again that only the split septum T-Connector recommended for use with the Hummi Micro Draw is the Nexus Micro T split septum T-Connector. The Nexus Micro T-Connector is designed to provide improved insertion force and eliminate potential leaking while providing a microbial barrier when used with the Hummi Micro Draw device. The Hummi Micro device manufactured in 2015 now has improved lubrication on the blunt tube which makes insertion into smaller septum opening of the Mexud Micro T-Connector smooth and easier to accomplish. The firm states in the letter that the distributor will offer
Quantity in commerce: 62,400
Distribution: US Distribution in the state of CA.
Product codes and lots: Lot Numbers: 20140510 20140513 20140516 20140519 20140603 20140606 20140609 20140612 14299

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1908-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1908-2016	Class I	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-05

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)