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;
FDA Recall Z-1127-2025 · Posted 2025-02-10
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Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeLRP
Date Initiated2024-11-08
Product Quantity973,785 total units
Reason for Recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Firm Action
An URGENT: MEDICAL DEVICE CORRECTION OVER LABEL notification letter dated 11/8/24 was sent to customers.
If you locate affected product within your facility, please complete the following:
1. QUARANTINE affected kits & ALERT your clinicians of this action
2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all CODMAN Patties & Strips included with the Presource product.
3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648.
Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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