Recall of Level 1 Normothermic IV Fluid Administration and Irrigation Sets
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.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.