BD is conducting a voluntary medical device recall for multiple lots of the BD PosiFlush™ SF (Sterile Field) Saline Flush Syringe 10mL identified in the Table above and Attachment A. This 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.
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 or interruption of treatment and user dissatisfaction or annoyance.
This recall affects the catalog and specific lot numbers referenced in this notification. BD distributed the affected recalled lots between February 28, 2019 through March 2, 2020. This recall does not affect any other products or lots. The lot number can be found on the syringe and case label. A picture showing the location of the lot number is included in Attachment B to assist you in identifying the recalled lots in your control.
There have been no reports of adverse events, injuries or deaths related to this recall to date.