Baxter Recalls Heparin Sodium Injections, Sierra Pre-Filled Expands Recall of Heparin and Normal Saline Pre-Filled Flushes
January 21st, 2008 amy
Over the weekend, Baxter Healthcare and the FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions. Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.
Baxter’s recall includes Heparin Sodium Injection 1000 units/mL 10mL Vial Lot numbers 107054 and 117085, as well as Heparin Sodium Injection 1000 units/mL 30mL Vial Lot numbers 047056, 097081, 107024, 107064, 107066, 107074, and 107111.
Also this weekend, AM2 PAT, Inc, doing business as Sierra Pre-Filled Inc, has issued a second notice that the company is expanding its nationwide recall to include all lots of both Heparin and Saline pre-filled flushes under the brand names of Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes. One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes has been found to be contaminated with Serratia marcescens, which has resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor.
