Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.
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 medical device with a risk of harm (endotoxin variability) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling 456 units of Presource Kits, specifically the HARMONIZED SPINE VCH PHC PACK (Catalog Number: SOP30SPBCC). The recall is due to unexpected variability in endotoxin levels found in the MEDICOM Ritmed Neurological Sponges contained within these kits.
The affected products were distributed nationwide in the United States and in Canada. The recall involves specific lots identified by UDI-DI 10195594687137 (each) and 50195594687135 (case), with lot numbers 12206 and 13289.
Healthcare facilities and consumers should stop using these kits and contact Cardinal Health for instructions on returning the product.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 456
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 (7)
- 1) SOP30SPBCC
- UDI-DI: 10195594687137(each)
- 50195594687135(case)
- Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿
- 2) SOP30SPBCC
- Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿
- 3) SOP30SPBCC
Distribution
Distributed nationwide across the United States.
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