Cardinal Health Presource Kits Recalled for Endotoxin Variability
Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.
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 medical device with a known contamination issue (endotoxin variability) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling 80 units of Cardinal Health Presource Kits, specifically the NEWNAN SMR PACK (Catalog Number: SEN21SPPMB). The recall affects kits distributed in the United States and Canada.
The recall was initiated because the kits contain MEDICOM Ritmed Neurological Sponges that were previously recalled due to unexpected variability in endotoxin levels. Endotoxins are substances found in the outer membrane of certain bacteria that can cause adverse reactions in patients.
Healthcare facilities and consumers who have these specific kits should stop using them immediately. Affected lots include Lot Number 15192 and Lot Number 15463-1. Users should contact Cardinal Health for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 80
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 (6)
- 1) SEN21SPPMB
- UDI-DI: 10888439504965(each)
- 50888439504963(case)
- Lot Number: 15192
- 2) SEN21SPPMB
- Lot Number: 15463-1
Distribution
Distributed nationwide across the United States.
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