Agency classClass IIOur severity:Severe FDA (Devices)·Z-2182-2013·Announced 2013-09-18

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.

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 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
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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