Products Affected - Description

• • 0.9% Sodium Chloride, Hikma, 2 mL vial, 25 count, NDC 00641-0497-25 - discontinued

Reason for the Shortage

• • In August 2021, Cardinal recalled three Monoject saline flush prefilled syringe products because the plunger may pull air into the syringe after the air has been expelled. Cardinal has made a business decision to no longer manufacture Monoject saline flush prefilled syringes. Additional information about the recall can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-nationwide-recall-select-monojecttm-flush-prefilled-saline-syringes
  • BD has Normal Saline Flush syringes (BD Posiflush) available.
  • Hikma is no longer marketing their normal saline flush syringes.
  • Medefil has Normal Saline Flush syringes available.

Available Products

• • BD Posiflush, BD, 10 mL standard plunger rod syringe, 30 count, NDC 08290-3065-46
  • BD Posiflush, BD, 3 mL fill in 10 mL syringe, 30 count, NDC 08290-3065-44
  • BD Posiflush, BD, 5 mL fill in 10 mL syringe, 30 count, NDC 08290-3065-45
  • Normal Saline Flush, Medefil, Inc., 10 mL fill in 12 mL syringe, 60 count, NDC 64253-0111-30
  • Normal Saline Flush, Medefil, Inc., 3 mL fill in 12 mL syringe, 60 count, NDC 64253-0111-33
  • Normal Saline Flush, Medefil, Inc., 3 mL fill in 6 mL syringe, 60 count, NDC 64253-0111-23
  • Normal Saline Flush, Medefil, Inc., 5 mL fill in 12 mL syringe, 60 count, NDC 64253-0111-35
  • Normal Saline Flush, Medefil, Inc., 5 mL fill in 6 mL syringe, 60 count, NDC 64253-0111-25
  • 0.9% Sodium Chloride, Fresenius Kabi, 2 mL vial, 25 count, NDC 63323-0186-02

• • Saline flush syringe conservation strategies can be found at https://www.fda.gov/medical-devices/letters-health-care-providers/prefilled-saline-flush-syringe-conservation-strategies-letter-health-care-personnel?utm_medium=email&utm_source=govdelivery