Cook Kwart Retro-Inject Ureteral Stent Set Recalled for Missing Warning
Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the instructions for use did not include a warning for stent knotting.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a missing warning label rather than a direct defect causing immediate harm, fitting the Moderate severity criteria for labeling errors.
Plain-English summary
Cook Inc. is recalling the Kwart Retro-Inject Ureteral Stent Set and Salle Intraoperative Pyeloplasty Stent Set. The recall was initiated because the Instructions for Use (IFU) for these products did not include a warning regarding the risk of stent knotting.
The affected products include various sizes of the Kwart Retro-Inject Ureteral Stent Set, including 4.7 Fr, 6.0 Fr, 7.0 Fr, and 8.0 Fr, as well as sets with AQ Hydrophilic Coating. The recall covers all lot codes. The distribution pattern indicates the products were distributed nationwide and to numerous foreign countries, including Australia, Canada, and various European and Asian nations.
Healthcare providers and facilities that have received these products should stop using them and contact Cook Inc. for further instructions. Patients who have had these stents placed should consult their healthcare provider regarding the potential risk of stent knotting.
The recalled product
- Product
- Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ¿ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr AQ-003500 G17150; 6.0 Fr
- Manufacturer
- Cook Inc.
- Affected units
- 12,968
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 lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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