B. Braun Normal Saline Flush Recall
September 19, 2007
B. Braun Medical Inc. recalled normal saline flush syringes due to increasing complaints of conspicuous particulate matter in the saline syringe. The particulate matter discovered in these syringes is a medical grade silicone which is biocompatible and routinely used in the medical device industry. To date, no documentation has been submitted linking the recalled product with adverse events; however, the likelihood of complications such as phlebitis and pulmonary embolism increases with exposure.
This nationwide recall involves normal saline 3 mL in 12 mL syringes (product code 513584) and normal saline 10 mL in 12 mL syringes (product code 513587). Affected products also contain the letters “SFR” in the lot numbers. The product code is not the same as the lot number for these products. The product code is identified as REF and the lot number is identified as LOT on the syringe label.
Immediately discontinue use of the recalled product. Consult a healthcare professional if any complications arise which may be related to the use of this product. Those in possession of product affected by the recall should contact B. Braun Medical Inc. Customer Support Department at (800) 227-2862 for product return information.
Additional information is available at the following link:
- MedWatch alert:
- Recall notice:
September 18, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.