Monoject Saline Flush Recall Due to Potential Sterility Compromise
Covidien LLC is recalling Monoject 0.9% Saline Flush Prefill Double Pouches because sterility may be compromised.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (sterility compromise) where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Covidien LLC is recalling Monoject 0.9% Saline Flush Prefill Double Pouches (Item Code: 8881570129) because the sterility of the product may be compromised. The recall involves 207,876 units distributed nationwide in the United States.
The affected product is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. The recall covers specific lot numbers, including P15035, P15036, P15037, P15041, P15042, P15046, P15047, P15048, P15049, P15056, P15057, P15058, P15059, P15063, P15064, P15069, P15070, P15071, P15078, P15079, P15080, P15081, and P15091.
Healthcare facilities and consumers should stop using the affected lots and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — IV Flush
- Hazard
- Affected units
- 207,876
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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