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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Level 1 Normothermic IV Fluid Administration and Irrigation Sets-Smiths Medical ASD, Inc.

DATE RECALL INITIATED:

July 23, 2007

PRODUCT / LOT NUMBER:

REF Codes: D-50, D-60HL, D-70, D-100, D-300, IR-40, IR-500, IR-600, IR-700

All products with an expiration date on or before July 2011

MANUFACTURER:

Smiths Medical ASD, Inc.
Rockland, MA

REASON:

Smiths Medical has become aware that some heat exchangers in the sets may have a leakage of the inner lumen which may allow the heating fluid to enter the patient fluid path or vice versa, which can cause contamination of the blood or solutions being infused or the recirculating solution.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448