Recall Z-1127-2025— Cardinal Health 200, LLC
Class II · Ongoing
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2024-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;. Reason: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-08
- Firm location
- Waukegan, IL, United States
Product description
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
Reason for recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.