Device 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
Z-2179-2013
Product summary
- Firm
- Covidien LLC
- Event
- Event 65978
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
device-enforcement:Z-2179-2013
Official wording
Reason: 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
Derived failure modes
-
Unknown
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin