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Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

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

Read the official notice at FDA (device) →

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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) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
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) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 3) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ;
Product quantity
456 kits
Voluntary mandated
Voluntary: Firm initiated
City
Waukegan
State
IL
Country
United States
Event id
99380
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