Drug Safety Alerts

BD PosiFlush Consumer-Level Recall

4/16/2020

On April 16, 2020, BD issued a consumer-level recall of PosiFlush™ Syringe 10 mL saline flush syringes NDC # 08290-3065-53. This recall was issued because the product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. While the sterility of the outer surface of the syringe may be compromised, the saline solution and the sterile path of the syringe are not impacted.

A complete list of the affected lot numbers is provided here.

When used in a sterile field, the compromised sterility due to holes in the packaging may increase the risk of infection to a patient, potentially leading to medical intervention and/or life-threatening injury. If the issue is identified prior to use and the syringe is discarded per standard clinical practice, this may lead to a delay in treatment and user dissatisfaction or annoyance.

According to BD, there have been no reports of adverse events, injuries or death related to this recall to date.

BD has advised that it is continuing to manufacture the BD PosiFlush™ SF Saline Flush Syringe product, but that it does not have an alternative sterile product, which may cause a slight delay in the fulfillment of replacement product. BD has further advised that if replacement product is not available, customers may look for an equivalent sterile prefilled product in the marketplace. Lastly, BD has advised that as an alternate practice, clinicians may choose to draw up normal saline for a sterile field using a sterile syringe and sterile needle as described in the “Association of Surgical Technologists Guidelines for Safe Medication Practices in the Perioperative Area” and following their hospital guidelines.

CVS Caremark Response:

CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using PosiFlush Syringe 10 mL saline flush syringes to contact their prescriber.

For more information, please contact BD at 1-888-364-2985, Monday through Friday, 8:00 AM to 5:00 pm (ET) or visit https://www.bd.com.You may also contact the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.