Agency classClass IIOur severity:Severe FDA (Devices)·Z-2181-2013·Announced 2013-09-18

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

FDA is recalling Monoject 10 Units/mL 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 hazard involves the administration of non-sterile water via intravenous access, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Monoject 10 Units/mL Heparin Lock Flush syringes, 12 mL syringes with 10 mL fill, manufactured by Covidien LLC. The recall is due to the potential presence of non-sterile water in the syringes, which are labeled as containing 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 product is identified by Lot Number 13A0084N. The distribution pattern for this recall includes the United States nationwide and Bermuda. The source text does not specify the exact quantity of units affected or the specific dates of distribution.

Healthcare providers and consumers should stop using the affected syringes immediately. The FDA advises that these products should not be used for intravenous administration due to the risk of introducing non-sterile water into the patient's bloodstream. Users should contact their healthcare provider or the manufacturer for further instructions on disposal or replacement.

The recalled product

Product: Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 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: non-sterile-water
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

See all →

Moderate
EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
Moderate
Covidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
Moderate
Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Covidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Shiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10

Same hazard · non sterile water