Cardinal Health Recalls Non-Sterile Monoject Bluntfill Syringes
Cardinal Health 200, LLC is recalling Monoject Bluntfill syringes that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.
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 involves a risk-of-harm product (infection) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling 8,000 units of Monoject Bluntfill with Filter, 18G x 1-1/2" syringes (Item Code 11811022F). The recall is due to a labeling error where the product package was labeled as both "STERILE" and "NON-STERILE," but the product did not undergo the sterilization process and is non-sterile.
The affected syringes are used for general purpose injection and aspiration of fluids from vials, ampules, and parts of the body below the surface of the skin. The use of a needle that is not sterile could result in infection. The firm is not aware of any reports of patient harm.
The affected product is identified by Lot No. 15072024, Item Code 11811022F, and an expiration date of 06/20/2020. The product was distributed worldwide, including nationwide in the United States and in Canada, Australia, South Africa, Belgium, Germany, Ireland, Portugal, Spain, and the UK.
The recalled product
- Product
- Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 8,000
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 (3)
- Lot No. 15072024
- Item Code 11811022F
- Expires 06/20/2020
Distribution
Part of a larger recall action
This product is one of 4 recalled by Cardinal Health 200, 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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