The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2179-2013·Announced 2013-09-18

Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination

FDA is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a medical device that may contain non-sterile water, posing a risk of infection or adverse health consequences, which aligns with the 'Severe' criteria for significant injury risk or Class II medical device recalls.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Monoject 0.9% Sodium Chloride Flush Syringes, 12 mL Syringe with 3 mL Fill, manufactured by Covidien LLC. The recall is due to the possibility that the syringes may contain non-sterile water, despite being labeled as saline or heparin. These are sterile, single-use products intended for flushing and locking compatible intravenous administration sets and indwelling intravenous access devices.

The affected product is identified by Product ID 8881570123 and Lot Number 13A0084N. The recall covers distribution in the United States nationwide and in Bermuda. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and consumers should stop using the affected syringes immediately. Users should check their inventory for the specific product ID and lot number listed above. If the product is found, it should be quarantined and returned to the distributor or manufacturer according to their instructions. This recall is a precautionary measure to prevent potential infection or adverse health effects from non-sterile contamination.

The recalled product

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…
Manufacturer
Covidien LLC
Category
Medical Device — Syringes
Hazard

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.

See all 9 products in this recall →

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