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Healthcare Product Company Recalls Non-sterile Syringes

Destiny Baker3 years ago

The FDA has issued a release stating that Covidien, a healthcare product company and medical device manufacturer, has recalled specific lots of their Monoject prefill flush syringes.

About the Unsterile Syringe Recall

  • According to the FDA, the recall was made after Covidien determined that a number of syringes may have been filled with water, but not run through the proper sterilization process.
  • The injection of non-sterile fluid may result in potentially fatal infections to the blood stream.
  • The products are labeled as sodium chloride flush or as heparin lock flush.

Description of the Recalled Syringes

  • Monoject 0.9% Sodium Chloride Flush Syringe, 12mL Syringe with 10mL Fill

    • Product ID: 8881570121
    • Lot Number: 13A0084N, 13A0094, 13B0364, 13C0504, 13C0514
  • Monoject 0.9% Sodium Chloride Flush Syringe, 12mL Syringe with 3mL Fill

    • Product ID: 8881570123
    • Lot Number: 13A0084N
  • Monoject 0.9% Sodium Chloride Flush Syringe, 12mL Syringe with 3mL Fill

    • Product ID: 8881570125
    • Lot Number: 13A0084N
  • Monoject 10 Units/mL Heparin Lock Flush, 12mL Syringe with 10mL Fill

    • Product ID: 8881580121
    • Lot Number: 13A0084N
  • Monoject 10 Units/mL Heparin Lock Flush, 12mL Syringe with 3mL Fill

    • Product ID: 8881580123
    • Lot Number: 13A0084N
  • Monoject 10 Units/mL Heparin Lock Flush, 12mL Syringe with 3mL Fill

    • Product ID: 8881580125
    • Lot Number: 13A0084N
  • Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10mL Fill

    • Product ID: 8881590121
    • Lot Number: 13A0084N
  • Monoject 100 Units/mL Heparin Lock Flush, 12mL Syringe with 3mL Fill

    • Product ID: 8881590123
    • Lot Number: 13A0084N
  • Monoject 100 Units/mL Heparin Lock Flush, 12mL Syringe with 5mL Fill

    • Product ID: 8881590125
    • Lot Number: 13A0084N, 13D0824N
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