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Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

Medical DevicesSource: FDA (device) · Date: 2026-08-19

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Cardinal Health 200, LLC
Product
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Reason / hazard
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide. Canada.
Recall initiated
2026-07-14
Code info
1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
Product quantity
80 kits
Voluntary mandated
Voluntary: Firm initiated
City
Waukegan
State
IL
Country
United States
Event id
99380
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