Cardinal Health Recalls Non-Sterile Monoject Hypodermic Safety Needles
Cardinal Health is recalling Monoject Hypodermic Safety Needles because they were shipped as non-sterile despite labeling indicating sterility, posing an infection risk.
What this means for you
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 risk 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 8,000 units of Monoject Hypodermic Safety Needles (30G x 1/2", Item Code 1183005). The recall is due to a labeling and processing error where the product was shipped to customers without undergoing the sterilization process, despite the package being labeled as "STERILE" and "NON-STERILE".
The affected needles are used for general purpose injection and aspiration of fluids. The use of non-sterile needles could result in infection. The firm is not aware of any reports of patient harm associated with this recall.
The affected product is identified by Lot No. 15063001 and has an expiration date of 05/31/2020. 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 and healthcare providers should stop using the affected needles and contact Cardinal Health for instructions on return or replacement.
The recalled product
- Product
- Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - 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
- 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. 15063001
- Item Code 1183005
- Expires 05/31/2020
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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