Normal Saline Flush Syringes Recalled By B. Braun Medical Inc. Due to Silicone Particulate ContaminationSep 17, 2007 | Parker Waichman LLP, LLP
B. Braun Medical Inc. has issued a recall for more than 1 million Normal Saline Flush syringes because the company has received customer complaints that the saline contains particulate matter. B. Braun says that it has notified the Food & Drug Administration of the recall, which affects Normal Saline Flush syringes with lot numbers ending in “SFR”.
The recall affects normal saline 3mL in 12mL syringes with the product code 518584 and normal saline 10mL in 12mL syringes with product code 51387. Between June 18 and July 18, 2007, B. Braun distributed about 33,000 units of the product code 513584 and 1.2 million units of the product code 513587 to hospitals and distributors. All of the lot numbers on the recalled syringes end in “SFR”. Both the product code, identified as “REF”, and lot number, identified as “LOT”, can be found on the syringe label below the product description.
The defective devices have been found to contain particulate matter identified as medical grade silicone. This particulate matter may pose a health risk. If the silicone is introduced into the blood stream, it could result in phlebitis or damage to other vital organs, including the brain, heart, kidneys, and lungs. There is also a risk that the particulate matter could cause the development of a pulmonary embolism or silicone embolism syndrome, which could lead to death. As of now, no injuries have been linked to the recalled B. Braun Normal Saline Flush syringes.
If the silicone particulate matter is introduced into the blood streams, symptoms would likely appear more than 24-48 hours after administration of the saline. However, B. Braun says that the risk associated with the use of the recalled syringes is cumulative, and increases with each additional exposure. A patient’s symptoms might not appear until they have received several doses. The symptoms of phlebitis include a slow onset of a tender, red area along the superficial veins on the skin. The area may feel hard, warm, itchy or swollen. It may also start to throb or burn and a low grade fever might be present. The symptoms of an embolism include shortness of breath, rapid breathing, chest pain, and blue discoloration around the lips and on the finger tips. A patient with an embolism might also exhibit a cough and could cough up blood.
Customers who have the B. Braun Medical Inc. Normal Saline Flush syringes should stop using them immediately and seek medical help if they experience any symptoms that could be related to the introduction of the silicone particulate matter. Customers can arrange to have the syringes replaced by calling the B. Braun Medical Inc. Customer Support Department at (800) 227-2862.