FDA Renews Nationwide Alert on IV Flush

The FDA has reissued a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by IV Flush and distributed by Pinnacle Medical Supply of Rowlett, Texas.

The alert was reissued because new cases of infections have been reported that may be associated with the use of these unapproved and possibly contaminated products.

The FDA last week warned consumers and institutions who have these preloaded syringes to not use them and to immediately return them to IV Flush or the original distributor. Since that initial warning FDA has been informed of a cluster of Pseudomonas fluorescens (P. fluorescens) infections in patients that may be associated with the heparin flushes. These cases are continuing to be investigated.

The heparin and sodium chloride containing intravenous flushes were sold to distributors who redistributed to other medical distributors and hospitals. Some of the intravenous flushes may have been provided to patients for home use. They can be identified by the syringe label, which reads in part, "IV Flush Dallas, TX."