Cardinal Health Recalls Neurological Procedure Kits Due to Endotoxin Variability
Cardinal Health is recalling specific 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 is classified as FDA Class II, and the hazard involves endotoxin variability in a medical device used in neurological procedures, which poses a risk of harm even without reported illnesses.
Plain-English summary
Cardinal Health 200, LLC is recalling specific Presource Kits, including various Neuro Crani Opt and ENT kits, because they contain MEDICOM Ritmed Neurological Sponges. The recall was initiated due to unexpected variability in endotoxin levels within these sponges.
The affected products were distributed nationwide in the United States and in Canada. The recall covers 401,311 kits across multiple catalog numbers and lot numbers.
Healthcare facilities and consumers should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by Cardinal Health.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP9
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 401,311
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 (20)
- 3790) SNE30CNRCD
- UDI-DI: 10195594687052(each)
- 50195594687050(case)
- Lot Number: 4730
- 3791) SNE30CNRCD
- Lot Number: 2221315564
- 3792) SNE30CNRCD
- Lot Number: 338058
- 3793) SNE30CNRCD
- Lot Number: 4869
- 3794) SNE30CNRCD
- Lot Number: 7784
- 3795) SNE30CNRCD
- 3796) SNE30CNRCD
- 3797) SNE30CNRCD
- 3798) SNE30CNRCD
- 3799) SNE30CNRCD
- Lot Number: 9243-1
- 3800) SNE30CNRCD
- Lot Number: 3024-2
Distribution
Distributed nationwide across the United States.
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