ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
FDA Recall Z-1636-2016 · Posted 2016-05-20
Recalling FirmHummingbird Med
Recall StatusTerminated
Product CodeKST
Date Initiated2015-10-01
Date Terminated2017-01-26
Product Quantity11500 units
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Distributed in the states of CA, KY, MD, GA, and IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.