openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 9
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
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Code information
Lot Numbers: 13A0084N 13A0094 13B0364 13C0514
Distribution pattern
Worldwide Distribution - USA Nationwide and the country of Bermuda
device · product 2 of 9
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
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Code information
Lot Numbers: 13A0084N
Distribution pattern
Worldwide Distribution - USA Nationwide and the country of Bermuda
device · product 3 of 9
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
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Code information
Lot Numbers: 13A0084N
Distribution pattern
Worldwide Distribution - USA Nationwide and the country of Bermuda
device · product 4 of 9
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
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Code information
Lot Numbers: 13A0084N
Distribution pattern
Worldwide Distribution - USA Nationwide and the country of Bermuda
device · product 5 of 9
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
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Code information
Lot Numbers: 13A0084N
Distribution pattern
Worldwide Distribution - USA Nationwide and the country of Bermuda
device · product 6 of 9
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
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Code information
Lot Numbers: 13A0084N
Distribution pattern
Worldwide Distribution - USA Nationwide and the country of Bermuda
device · product 7 of 9
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
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Code information
Lot Numbers: 13A0084N
Distribution pattern
Worldwide Distribution - USA Nationwide and the country of Bermuda
device · product 8 of 9
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
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Code information
Lot Numbers: 13A0084N
Distribution pattern
Worldwide Distribution - USA Nationwide and the country of Bermuda
device · product 9 of 9
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
