Covidien LLC: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Agency Publication Date: September 10, 2013

Affected Products

Product: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N 13A0094 13B0364 13C0514

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Product: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Product: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Product: Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Product: Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Product: Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Product: Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Product: Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Product: Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

Lot Numbers: 13A0084N 13D0824N

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65978

Status: Resolved

Manufacturer: Covidien LLC

Manufactured In: United States

Units Affected: 9 products (3,235,860 units; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; 330,120 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Numbers: 13A0084N 13A0094 13B0364 13C0514

Lot Numbers:

Numbers

Lot Numbers: 13A0084N

Lot Numbers:

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Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Lot Numbers: 13A0084N

Lot Numbers:

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Lot Numbers: 13A0084N

Lot Numbers:

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Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Lot Numbers: 13A0084N

Lot Numbers:

Numbers

Lot Numbers: 13A0084N 13D0824N

Lot Numbers:

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