Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog
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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) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B
- 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) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 14039 ; 2) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 3) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 4) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14039 ; 5) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192-1 ; 6) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-5 ; 7) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 8) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 9) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14813 ; 10) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192 ; 11) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-1 ; 12) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-6 ; 13) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-7 ; 14) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-1 ; 15) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 6033 ; 16) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160-2 ; 17) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 10392 ; 18) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-2 ; 19) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 11020 ; 20) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1 ; 21) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160 ; 22) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1
- Product quantity
- 616 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukegan
- State
- IL
- Country
- United States
- Event id
- 99380
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