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8607 Roberts Drive, Suite 150 Sandy Springs, GA 30350-2237

(770) 518-8272phone    (770) 518-3310fax

8607 Roberts Drive, Suite 150 Sandy Springs, GA 30350-2237

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BD Medical Voluntarily Recalls BD PosiFlush™ SF Saline Flush Syringe 10mL

 

On April 16, BD Medical announced a voluntary recall for multiple lots of BD PosiFlush™ SF (Sterile Field) Saline Flush Syringe 10 mL. Eleven lot numbers were affected. Hemophilia of Georgia and Beacon pharmacies dispensed items from six of the lot numbers, including:

  • 9011582
  • 9017875
  • 9045702
  • 9060999
  • 9079716
  • 9143529

The lot number can be found on the syringe and case label. A full list of lot numbers is provided below.

We shipped affected product to a total of 88 pharmacy clients, including 71 HoG and Beacon clients (in Georgia) and 17 clients to the HTCs in Florida. If you have a product affected by this recall, dispose of the product immediately. We will replace these items for our clients as quickly as possible. If we run out of sterile saline, we will temporarily replace the product with non-sterile saline. If you have questions about using non-sterile saline, please contact your outreach nurse or call HoG at 770-518-8272.

For those living in Georgia, your outreach nurse will contact you with more details. Florida clients will be contacted by your local Hemophilia Treatment Center.

The recall was made because BD Medical identified 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.

This recall affects products with the unique device identification number (UDI) 50382903065535 and catalog reference number 306553. BD distributed the affected recalled lots between Feb. 28, 2019, through March 2, 2020. This recall does not affect any other products or lots.

There have been no reports of adverse events, injuries or deaths related to this recall to date. BD continues to manufacture the BD Posiflush™ SF Saline Flush Syringe product and replacement orders will be prioritized. As BD does not have an alternative sterile product, this may cause a slight delay in the fulfillment of replacement product. BD understands that supply interruptions can impact our customers’ ability to provide the best care for their patients and takes this matter very seriously. If BD product is not available, customers may look for an equivalent sterile prefilled product in the marketplace. Lastly, 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 int eh “Association of Surgical Technologists Guidelines for Safe Medication Practices in the Perioperative Area” and following their hospital guidelines.

Lot Numbers in This Recall:

8353952        9011582        9017875        9024676        9045702


9060999      9079716        9127571         9143529       9156595


9163601