Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBY
FDA device recall Z-1130-2025 · posted 2025-02-10 · Open, Classified
Recall details
- Recalling firm
- Cardinal Health 200, LLC
- Reason for recall
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- OFX
- Quantity affected
- 973,785 total units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
- Date initiated
- 2024-11-08
- Date posted
- 2025-02-10
- Location
- Waukegan, IL
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