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Open, Classified

Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC

FDA Recall Z-1133-2025 · Posted 2025-02-10

Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeOJF
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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