Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject 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 presence of non-sterile water in a sterile medical device intended for intravenous use poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Monoject 10 Units/mL Heparin Lock Flush syringes (Product ID: 8881580123) manufactured by Covidien LLC. The recall is due to the possibility that the syringes contain non-sterile water rather than the sterile saline or heparin solution indicated on the label.
These sterile, single-use syringes are intended for flushing and locking compatible intravenous administration sets and indwelling intravenous access devices. The affected lot number is 13A0084N. The products were distributed nationwide in the United States and in Bermuda.
Healthcare facilities and consumers should stop using the affected syringes immediately. Users should contact their healthcare provider or the manufacturer for further instructions on how to manage the recall and ensure patient safety.
The recalled product
- 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
- 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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