Cardinal Health Recalls Non-Sterile Monoject Syringes with Safety Needles
Cardinal Health is recalling Monoject 3mL syringes with safety needles because they were shipped as non-sterile despite labeling. The firm is not aware of any patient harm reports.
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 from non-sterile needles) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling 8,400 units of Monoject 3mL Syringes with Hypodermic Safety Needles (22G x 1-1/2, Item Code 11832215). The recall was initiated because the product was shipped to customers in a non-sterile state, even though the packaging was labeled as both "STERILE" and "NON-STERILE." The product did not undergo the required sterilization process.
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 specific lot number is 15072015, and the expiration date is 06/20/2020. The distribution was worldwide, including the United States, Canada, Australia, South Africa, Belgium, Germany, Ireland, Portugal, Spain, and the UK.
The use of a non-sterile needle could result in infection. Cardinal Health is not aware of any reports of patient harm associated with this recall. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - 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
- Hazard
- Affected units
- 8,400
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. 15072015
- Item Code 11832215
- 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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