Agency classClass IIOur severity:Severe FDA (Devices)·Z-2185-2013·Announced 2013-09-18

Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water

FDA Class II recall of Monoject 100 Units/mL Heparin Lock Flush syringes due to potential non-sterile water contamination.

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. According to the rubric, FDA Class II recalls involving potential contamination that could lead to hospitalization or significant injury are rated as Severe (4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill (Product ID: 8881590123). The recall is being conducted by the manufacturer, Covidien LLC, because the prefill flush syringes may contain non-sterile water while being labeled as saline or heparin.

The affected product is a sterile, single-use medical device intended for flushing and locking compatible intravenous administration sets and indwelling intravenous access devices. The specific lot number involved in this recall is 13A0084N. The product was distributed nationwide in the United States and in Bermuda.

Healthcare providers and consumers should stop using the affected syringes immediately. Users should check their inventory for the specific lot number listed above. If the product has already been used, individuals should monitor for signs of infection or other adverse reactions and consult a healthcare professional if necessary.

The recalled product

Product: Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 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 — IV Flush Syringes
Hazard: contamination
infection-risk

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 →

Same manufacturer · Covidien LLC

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