Recall Z-1908-2016 ยท KST System, Blood Collection, Vacuum-Assisted, Manual
Hummingbird Med
ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
| Date | Jul 5, 2016 (initiated Mar 11, 2015) |
| Status | Terminated |
| Reason | Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties. |
| 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 wit |
| Quantity | 62,400 |
| Distribution | US Distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.