Cardinal Health Recalls Non-Sterile Hypodermic Safety Needles
Cardinal Health is recalling Monoject Hypodermic Safety Needles 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 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 Monoject Hypodermic Safety Needles, 25G x 5/8" (Item Code 1182558), because the product was shipped to customers in a non-sterile state despite being labeled as "STERILE". The product package was also labeled "NON-STERILR". The needles did not undergo the sterilization process.
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 lot number is 15063004, with an expiration date of 5/31/2020.
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. Consumers should stop using the affected needles and contact Cardinal Health for further instructions.
The recalled product
- Product
- Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - 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 — Needles
- Hazard
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. 15063004
- Item Code 1182558
- Expires 5/31/2020
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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