FDA MedWatch - Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect

Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect

AUDIENCE: Risk Manager, Nursing, Pediatrics

ISSUE: Hummingbird Med Devices Inc. is recalling the Hummi Micro-Draw Blood Transfer Device because the Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage. Blood or fluid loss may result in serious adverse health consequences, including death.

This recall includes:

• ABG-HM-1 Hummi Micro-Draw Blood Transfer Device
• Lot numbers: 15180, 15286, 15287, 15300, 15305
• Manufacturing dates: June 29, 2015 to December 2, 2015
• Distribution dates: October 26, 2015 to November 18, 2015
• Devices recalled in the U.S.: 37,750 units in California, Kentucky, Maryland and Illinois

See the FDA Recall Notice for a product photo. 

BACKGROUND: The Hummi Micro-Draw Blood Transfer Device is a blood collection device with a Y-shaped connector attached to a yellow cannula hub (tube). It connects to a catheter to collect small volume blood samples from infants, including premature ones. The collected blood is transferred from the device to a syringe or other container for transport and processing. The device is primarily used in hospitals.

RECOMMENDATION: On October 1, 2015, Hummingbird Med Devices Inc. sent notification letters to affected customers informing them that:

1. The firm recommends not using the identified lots;
2. A local distributor or sales representative will be contacting them to arrange a return of the identified lot for credit and replacement;
3. Replacement product should be available within 10 days of October 30, 2015; and
4. During the period of product unavailability customers should return to previous methods for blood drawing.

On November 19, 2015, the firm expanded this recall to include additional lots of the device. The firm sent a second notification letter to affected customers with the same instructions as in the October 30, 2015 letter, but stated that the replacement product would be available mid-December 2015.

The firm requested a Reply Form be completed and returned via fax at 949-583-2775.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm503695.htm

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