ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Periphe

FDA device recall Z-1636-2016 · posted 2016-05-20 · Terminated

Recall details

Recalling firm

Hummingbird Med

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.

Action taken

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 JorgeHaider@hummingbirdmed.com. 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

Status

Terminated

Product code

KST

Quantity affected

11500 units

Distribution

Distributed in the states of CA, KY, MD, GA, and IL.

Date initiated

2015-10-01

Date posted

2016-05-20

Date terminated

2017-01-26

Location

Lake Forest, CA