Cook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Error
Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.
What this means for you
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: The recall involves a medical device defect that could cause patient injury (introduction of a stiff tip instead of a flexible one), but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 13,388 units of the Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter. The affected products include Global Product Numbers G19108, G14587, G15302, and G14326. The recall covers specific lot codes: 8018728, 8080823, 8314382, 8409523, 8023194, and 7857489.
The recall was initiated because the wire guide may be incorrectly loaded into the wire guide holder. This error can lead to the stiff tip of the wire guide being introduced into the patient instead of the intended flexible tip. The agency has classified this as a Class II recall.
The products were distributed domestically across the United States and internationally to numerous countries, including Australia, Canada, China, Germany, Japan, and the United Kingdom. Healthcare facilities and distributors should stop using the affected products and contact Cook Inc. for instructions on return or replacement.
The recalled product
- Product
- Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
- Manufacturer
- Cook Inc.
- Affected units
- 13,388
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)
- 8018728 8080823 8314382 8409523 8023194 7857489
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Cook Inc. 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.
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