Cook Stent Sets Recalled for Missing Warning About Stent Knotting
Cook Inc. is recalling Kwart RetroInject and Salle Intraoperative Pyeloplasty 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 corresponds to a Moderate severity score (2) when no specific injuries or hospitalizations are reported in the source text, and the hazard is a missing warning label rather than a direct contamination or defect causing immediate harm.
Plain-English summary
Cook Inc. is recalling the Kwart RetroInject Stent Set (Multi-Length) and the Salle Intraoperative Pyeloplasty Stent Set. The recall is due to a labeling deficiency where the Instructions for Use (IFU) did not include a warning regarding the risk of stent knotting.
The affected products include specific catalog numbers for 4.0 Fr and 4.7 Fr stent sets. The recall covers 3,711 units distributed nationwide and in numerous foreign countries, including Australia, Canada, and various European and Asian nations. All lot codes are included in this recall.
This is a Class II recall, indicating that use of or exposure to the product could cause temporary or medically reversible adverse health consequences. Users should consult the recall notice for specific instructions on how to handle the affected devices.
The recalled product
- Product
- Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
- Manufacturer
- Cook Inc.
- Affected units
- 3,711
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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