ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
Recall
- Recall Number
- Z-1636-2016
- Event Number
- 72350
- Firm
- Hummingbird Med
- FEI Number
- 3009382876
- Product Code
- KST
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- October 1, 2015
- Posted
- May 20, 2016
- Terminated
- January 26, 2017
- Address
- 20371 Lake Forest Dr, Ste A6, Lake Forest, CA, 92630-8106
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.
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.
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.
Distributed in the states of CA, KY, MD, GA, and IL.
11500 units