Cook Inc. Recalls Bush Ureteral Illuminating Catheter Sets Due to Overheating Risk
Cook Inc. is recalling Bush DL and SL Ureteral Illuminating Catheter Sets because the devices may overheat, melt, and burn patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of burn injury to patients, which aligns with the rubric criteria for Severe severity (Class II with potential for significant injury).
Plain-English summary
Cook Inc. is voluntarily recalling Bush DL and Bush SL Ureteral Illuminating Catheter Sets. The recall was initiated because the devices may overheat, melt, and burn the patient during use.
The recall covers 19,756 units distributed within the United States and internationally to the Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jersey, Kuwait, Mexico, Morocco, New Zealand, Norway, Panama, Paraguay, Portugal, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Trinidad and Tobago, United Arab Emirates, and the United Kingdom. All lots are affected.
Healthcare providers and facilities should stop using these devices immediately and contact Cook Inc. for instructions on return or replacement. Patients who have used these devices should contact their healthcare provider if they experience any adverse effects.
The recalled product
- Product
- Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 19,756
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 (1)
- All lots.
Distribution
Distribution scope not specified by the agency.
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