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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification: Hotline L-10 Gas Vent-Smiths Medical ASD, Inc

DATE NOTIFICATION INITIATED:

August 2, 2005

PRODUCTS / LOT NUMBERS:

HOTLINE L-10 Gas Vent (used on Hotline and Hotline 2 fluid warming devices)

Lot Numbers: 200505WM, 200506AM, 200506MM, 200506PM, 200506RM, 200506UM, 200506YM

MANUFACTURER:

Smiths Medical ASD, Inc.
Rockland, MA

REASON:

Smiths Medical issued an “Important: Advisory Notice” to notify consignees of a labeling error concerning the L-10 Gas Vent. During a recent labeling update the dispenser box and shipping carton labeling were inadvertently changed to include a symbol and a statement that the product is “latex-free.” However, this product contains two natural rubber latex discs, one on each side of the device. The primary label of the device, and the Instructions For Use, accurately state that the product contains Natural Rubber Latex.

Consignees may contact Customer Service to replace the affected device.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002