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Moderate riskFDA DeviceClass II

Cardinal Health Presource kit recalled for variable endotoxin levels

Cardinal Health is recalling 80 Presource Newnan SMR procedure kits (catalog SEN21SPPMB) because they contain MEDICOM Ritmed Neurological Sponges with unexpected variability in endotoxin levels. The affected kits are from lots 15192 and 15463-1 and were distributed across the US and to Canada. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls

What to do

  1. Check the lot number on your Presource Newnan SMR kit (SEN21SPPMB) to see if it is lot 15192 or 15463-1.
  2. If your kit is from an affected lot, do not use it and contact Cardinal Health for return or replacement instructions.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 8 products — see all of them.

Details

Units affected
80 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Classification
Class II
Recall number
Z-2944-2026

In the FDA's words

Description
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. 1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1 Distribution: US Nationwide. Canada. Affected quantity: 80 kits
Hazard
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

8 products in this recall

Cardinal Health Presource kits recalled for endotoxin variability

Cardinal Health is recalling 8 Presource procedure kit product groups, sold under the Cardinal Health Presource Kits name, that contain MEDICOM Ritmed Neurological Sponges. The sponges had unexpected variability in endotoxin levels. The kits were distributed across the US and to Canada, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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