FDA Recall - Intravenous catheter sites that have grown Pseudomonas fluorescens <Missouri>

Missouri Department of Health & Senior Services
For Immediate Release:
February 22, 2005

Since FDA's recall of this product in 1/05, new cases bring the total reported cases in MN, MO, NY, and TX to 30. Report cases to state and local health departments and CDC's DHQP at (404) 639-2303.

Since December 2004, an estimated total of 30 patients in Minnesota, Missouri, New York, and Texas have had cultures of blood or intravenous catheter sites that have grown Pseudomonas fluorescens. All of the patients had indwelling central venous catheters that had been flushed with a heparin and saline solution prepared by IV Flush, LLC, and distributed by Pinnacle Medical Supply (Rowlett, Texas).

The solution comes in prepackaged syringes that are ready for use. Microbial testing of unopened syringes has identified that multiple lots of this product are intrinsically contaminated with P. fluorescens. On January 31, 2005, the Food and Drug Administration (FDA) recalled all intravenous flush products made by this company. On February 4, the FDA nationwide alert was reissued in response to new contaminations. The full text of that notice can be accessed at:
http://www.fda.gov/bbs/topics/news/2005/NEW01154.html. Additional cases of other Pseudomonas species found in patients who received this product are also under investigation.

Persons who have positive results for Pseudomonas species from blood or catheter site cultures obtained from October 1, 2004, to the present and who have received IV flushes made by this company should be reported to state and local health departments and to CDC's Division of Healthcare Quality and Promotion at (404) 639-2303.

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