Cardinal Health Recalls McKesson Prevent M Needles Due to Safety Shield Defect
Cardinal Health is recalling 108,000 McKesson Prevent M needles because the safety shield may fail to lock, posing a risk of needlestick injuries and exposure to bloodborne pathogens.
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 (needlestick injury and bloodborne pathogen exposure) where specific injuries have not yet been reported, fitting the High severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling 108,000 units of McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8" (Lot Code: 028603). These single-lumen needles are intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
The recall was initiated because the safety shield may not lock into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur, creating the potential for exposure to bloodborne pathogens.
The affected products were distributed worldwide, including nationwide in the United States and in the countries of AE and Japan. Users should stop using the affected needles and contact Cardinal Health 200, LLC for further instructions.
The recalled product
- Product
- McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 26558
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Needles
- Affected units
- 108,000
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 (1)
- Lot Code: 028603
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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