Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (non-sterile water in a sterile product) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Monoject 10 Units/mL Heparin Lock Flush syringes (Product ID: 8881580125) manufactured by Covidien LLC. The recall is due to the potential presence of non-sterile water in the syringes, which are labeled as 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 lot number is 13A0084N. The products were distributed nationwide in the United States and in Bermuda. The source text does not specify the total quantity of units recalled or the specific dates of distribution.
Healthcare providers and consumers should stop using the affected syringes and contact their supplier or the manufacturer for further instructions. The FDA advises that these products should not be used in patients due to the risk of introducing non-sterile water into the body.
The recalled product
- Product
- 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
- 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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Same hazard · non sterile water
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FDA (Devices) · 2013-09-18
- SevereMonoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
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