U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.
Distributed in the states of CA, KY, MD, GA, and IL.
제품 설명
ABG-HM-1 Hummi Micro Draw Blood Transfer Device || Product Usage: || It is used for blood transfer and collection from Peripheral Arterial Line Catheters.