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U.S. Department of Health and Human Services

Class 1 Device Recall Hummi

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  Class 1 Device Recall Hummi see related information
Date Initiated by Firm March 11, 2015
Date Posted July 05, 2016
Recall Status1 Terminated 3 on February 07, 2017
Recall Number Z-1908-2016
Recall Event ID 73461
Product Classification System, blood collection, vacuum-assisted, manual - Product Code KST
Product ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
Code Information Lot Numbers: 20140510 20140513 20140516 20140519 20140603 20140606 20140609 20140612 14299
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 the Hummi Micro Draw because of insertion difficulties.
FDA Determined
Cause 2		 Process design
Action The firm, Hummingbird Med Devices, Inc., sent a "Safety Alert" on March 3, 2015 and Addendum on March 11, 2015, to all affected customers. The notification sent on March 3, 2015, instructed customers that: 1) the Hummi Micro device is not recommended to be used with the Baxter Interlink device with the Hummi Micro draw blood transfer device as the Interlink T Connector septum may be damaged. 2) the use of Nexus Medical Micro-T Split Septum T Connector NMT8046 with all uses of the Hummi Micro Draw Blood Transfer device. The connector has been tested and validated for use in combination with the Ameritus Medical's Hummi Micro-Draw Blood Transfer Device. 3) Distributors of the Hummi Micro Draw Device contact and inform all Hummi Micro-Draw Blood Transfer Device users to recommend change to the Nexus Split Septum Micro-T Connector NMT8046 for all uses with the Hummi Micro Draw device. Inservice materials and training on proper Hummi Micro Draw device blunt cannula insertion into the connector's septum will be provided. 4) Distributors complete the attached form indicating hospitals and date contacted, name, and contact information of responsible person and resulting outcome. and 5) Scan and email the attached form to: jorgehaider@humigbirdmed.com or fax to: 1-949-583-2775. On March 11, 2015, the firm sent out a second email to their distributor to inform customers again that only the split septum T-Connector recommended for use with the Hummi Micro Draw is the Nexus Micro T split septum T-Connector. The Nexus Micro T-Connector is designed to provide improved insertion force and eliminate potential leaking while providing a microbial barrier when used with the Hummi Micro Draw device. The Hummi Micro device manufactured in 2015 now has improved lubrication on the blunt tube which makes insertion into smaller septum opening of the Mexud Micro T-Connector smooth and easier to accomplish. The firm states in the letter that the distributor will offer
Quantity in Commerce 62,400
Distribution US Distribution in the state of CA.
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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