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U.S. Department of Health and Human Services

Class 1 Device Recall ABGHM1 Hummi Micro Draw Blood Transfer Device

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  Class 1 Device Recall ABGHM1 Hummi Micro Draw Blood Transfer Device see related information
Date Initiated by Firm October 01, 2015
Date Posted May 20, 2016
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-1636-2016
Recall Event ID 72350
Product Classification System, blood collection, vacuum-assisted, manual - Product Code KST
Product ABG-HM-1 Hummi Micro Draw Blood Transfer Device

Product Usage:
It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
Code Information Lot 15180, 15286, 15287, 15300, 15305
Recalling Firm/
Manufacturer		 Hummingbird Med
20371 Lake Forest Dr Ste A6
Lake Forest CA 92630-8106
For Additional Information Contact
760-585-6525
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
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 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.
Quantity in Commerce 11500 units
Distribution Distributed in the states of CA, KY, MD, GA, and IL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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