Cardinal Health Recalls Presource Kits Contaminated with Needle Particulate
Cardinal Health is recalling Presource surgical kits because they contained BD SafetyGlide needles with loose polypropylene particulate in the fluid path.
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 (foreign particulate in a needle) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling 184,102 Presource(R) custom surgical and procedural kits. These kits are distributed nationwide in the United States and internationally to Canada. The kits contain various disposable medical devices required for common surgical and other medical procedures.
The recall is due to the presence of BD SafetyGlide 22GA 1-inch needles within the kits. BD recalled these specific needles because loose polypropylene particulate in the fluid path could be expelled out of the needle during injection. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities and consumers should stop using the affected Presource kits and contact Cardinal Health for further instructions. The affected lots are identified by specific catalog and lot numbers listed in the official recall notice.
The recalled product
- Product
- Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 184,102
Distribution
Distributed nationwide across the United States.
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