Drug Safety Alerts

BD Syringes Patient-Level Recall

5/4/18

On May 4, 2018, BD issued a patient-level recall of BD PosiFlush™ and BD™ Pre-Filled Normal Saline Syringes. This recall was issued due to a potential for contamination with Serratia marcescens bacterium.

Out of an abundance of caution and in the interest of public health, BD is voluntarily recalling certain lots of BD PosiFlush™ Heparin Lock Flush and BD™ Pre-Filled Normal Saline Flush syringes due to a potential for contamination with Serratia marcescens bacterium. BD was notified by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) about a potential epidemiological link between catheter related blood stream infections and the S. marcescens bacterium.

Specifically, the FDA and CDC identified a potential connection between reports of infection in a small number of patients caused by S. marcescens across multiple states. CDC’s initial investigation found that affected patients had received treatment using certain BD flush products.

To date, there is no evidence of BD flush product testing positive for this bacterium. Investigations are ongoing by BD, FDA, and CDC.

Please note: This recall was originally issued to the retail-level on April 25, 2018. The recall was elevated to the patient-level on May 7, 2018.

A complete list of the affected products and lot numbers is provided at the end of this here:

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is sending letters to patients who received this product through CVS Caremark Mail Service Pharmacy and their physicians.

For more information, health care providers may contact the BD Urgent Product Recall Line at 1‑866-660-8973 or visit www.BD.com. You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.