FDA product recalls

September 27, 2007

Information on voluntary recalls of Dole packaged salads called Dole Hearts Delight sold in the US and Canada, and B. Braun Medical's Normal Saline Flush syringes .

On September 17‚ Dole Fresh Vegetables announced a voluntary recall of all packaged salads named Dole Hearts Delight‚ sold in the US and Canada with a “Best if Used by Date” of September 19‚ 2007. Production codes A24924A and A24924B are stamped on the packages. The package UPC code is 071430-01038.

While Dole has not received any reports of illness from the salads‚ a random screening in a Canadian grocery store found a package contaminated with E coli O157:H7. Consumers are urged to dispose of these products‚ and may call the toll-free Dole Consumer Center at 800-356-3111‚ with any questions.

On September 14, B. Braun Medical issued a voluntary nationwide recall of its Normal Saline Flush syringes with lot numbers ending in “SFR”‚ as a result of complaints of particulate matter in the saline. The particulate matter is medical grade silicone. According to the release‚ “introduction of particulate matter into the blood stream may result in phlebitis and/or damage to vital organs.”

Symptoms would likely develop within the first 24 to 48 hours of product administration‚ however‚ effects are cumulative so the risk to patients increases each time the saline flush is used. The recall affects normal saline 3 mL in 12-mL syringes with the product code 513584 and normal saline 10 mL in 12-mL syringes with the product code 513587. B. Braun estimates that 33,000 syringes with the product code 513584‚ and 1.2 million syringes with the product code 513587‚ were distributed between June 11 and July 18‚ 2007.

Customers are urged to immediately discontinue use of the product and to contact their health care provider if any problems arise. Clinicians can report problems to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm. To date‚ no adverse events have been reported.