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: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;
USCardinal 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: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;
Recalling Firm: Cardinal Health 200, LLC
Reason for Recall / Hazard
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Product Description & Identification
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: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;
Affected Products
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: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;
Additional Source Details
| Field | Value |
|---|---|
| City | Waukegan |
| State | IL |
| Event id | 99380 |
| Address 1 | 3651 Birchwood Dr |
| Code info | 3790) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 4730 ; 3791) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 2221315564 ; 3792) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 338058 ; 3793) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 4869 ; 3794) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3795) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3796) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3797) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3798) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ... [TRUNCATED] |
| Postal code | 60085-8337 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 401311 kits |
| Reason for recall | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260714 |
| Initial firm notification | Letter |
| Center classification date | 20260813 |
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Overview
- Recalling FirmCardinal Health 200, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide. Canada.
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🚨 SAFETY ALERT: Cardinal Health 200, LLC - 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: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC; Check if your household is affected: https://therecallfile.com/recalls/cardinal-health-presource-kits-1-chi-std-neuro-crani-opt-2-catalog-num/FDA-Z-2947-2026
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