Z-1636-2016 Class I Terminated
FDA device recall Z-1636-2016 was initiated by Hummingbird Med on October 1, 2015 and is designated Class I. 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 eno… The recall status is terminated (terminated January 26, 2017). Affected quantity: 11500 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2016
- Initiation Date
- October 1, 2015
- Termination Date
- January 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11500 units
Product Description
ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
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.
Distribution Pattern
Distributed in the states of CA, KY, MD, GA, and IL.
Code Information
Lot 15180, 15286, 15287, 15300, 15305