FDA-Device2013-09-18Class II

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

Covidien LLC
Hazard

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

Sold states
Worldwide Distribution - USA Nationwide and the country of Bermuda
Affected count
Unknown
Manufactured in
15 Hampshire Street, N/A, Mansfield, MA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2181-2013

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