B. Braun Medical, Inc., is recalling over a million normal saline flush syringes because they may contain particles of medical grade silicone. Introducing these particles into the bloodstream could cause phlebitis and organ damage, and possibly pulmonary embolism. The risk is cumulative, and would increase with each additional exposure.
The recall affects normal saline 3 mL in 12 mL syringes, product code 513584, and normal saline 10mL in 12mL syringes, product code 513587. The lot numbers of the recalled syringes end in "SFR." These syringes are used in both healthcare facilities and in caring for patients at home.
Anyone with the recalled syringes should immediately discontinue using them and seek medical attention if they've experienced symptoms that may be related to the product. To arrange for replacement syringes, contact B. Braun at 800-227-2862.
FDA Patient Safety News: November 2007
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=69#3
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