Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the administration of non-sterile water via intravenous access, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Monoject 10 Units/mL Heparin Lock Flush syringes, 12 mL syringes with 10 mL fill, manufactured by Covidien LLC. The recall is due to the potential presence of non-sterile water in the syringes, which are labeled as containing saline or heparin. These sterile, single-use products are intended for flushing and locking compatible intravenous administration sets and indwelling intravenous access devices.
The affected product is identified by Lot Number 13A0084N. The distribution pattern for this recall includes the United States nationwide and Bermuda. The source text does not specify the exact quantity of units affected or the specific dates of distribution.
Healthcare providers and consumers should stop using the affected syringes immediately. The FDA advises that these products should not be used for intravenous administration due to the risk of introducing non-sterile water into the patient's bloodstream. Users should contact their healthcare provider or the manufacturer for further instructions on disposal or replacement.
The recalled product
- 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
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Syringes
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 13A0084N
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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