Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination
Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of medical devices with potential endotoxin contamination in sterile surgical supplies. While no illnesses have been reported, endotoxin contamination poses a risk in surgical applications.
Plain-English summary
Cardinal Health Presource Kits for robotic urology procedures are being recalled due to potential endotoxin contamination in the surgical strips and patties included in these kits. Approximately 973,785 units are affected, distributed in the United States and internationally to Canada and Saudi Arabia.
The recall was classified as FDA Class II. Three catalog numbers are involved in this action: SOT4FRUWFA, SOT4FRUWFB, and SOT4FRUWFC.
Healthcare facilities that have received these kits should check their inventory against the recalled lot numbers and catalog numbers. Healthcare providers should discontinue use of affected supplies immediately.
Affected parties should contact Cardinal Health for instructions on returning recalled kits and obtaining replacements. Any adverse events or health concerns related to use of these kits should be reported to the FDA.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 973,785
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 1) SOT4FRUWFA
- UDI-DI:10197106526187 (each) 50197106526185 (case)
- Lot Number: 7266123
- 2) SOT4FRUWFA
- Lot Number: 7331357
- 3) SOT4FRUWFB
- UDI-DI:10197106627891 (each) 50197106627899 (case)
- 4) SOT4FRUWFB
- Lot Number: 7333452
- 5) SOT4FRUWFB
- Lot Number: 7333453
- 6) SOT4FRUWFC
- UDI-DI:10197106732304 (each) 50197106732302 (case)
- Lot Number: 7350031
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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