Cook Kwart RetroInject Stent Set Recall: Risk of Stent Knotting
Cook recalls specific ureteral stent sets due to missing warning for stent knotting. Affected models include 4.7 Fr, 6.0 Fr, and 7.0 Fr sizes with certain lot codes. No action is required as the hazard is not severe enough to warrant immediate stop use.
Lower-risk recall
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
Contact the company
What happened, in plain English
Cook is recalling specific ureteral stent sets that lack a warning about stent knotting. This could potentially cause complications during medical procedures, but the recall does not require immediate action. Read more at govinfonow.com/recall/68105-cook-kwart-retroinject-stent-set-recall-risk-of-stent-knotting.
Source Summary by GovInfoNow · govinfonow.com/recall/68105-cook-kwart-retroinject-stent-set-recall-risk-of-stent-knotting · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1369-2019
Cite this page
“Cook Kwart RetroInject Stent Set Recall: Risk of Stent Knotting.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68105-cook-kwart-retroinject-stent-set-recall-risk-of-stent-knotting. Based on FDA recall #Z-1369-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2019%22&limit=1).
Why it’s dangerous
The stent sets do not include a warning about knotting, which could lead to complications during medical procedures. Knotting might cause blockages or require additional interventions if not detected.
Who’s affected
Medical professionals using the Cook Kwart RetroInject stent sets for urological procedures are most at risk. Patients receiving these stents during surgery may also be affected.
How to tell if you have this one
Check for product labels with sizes 4.7 Fr, 6.0 Fr, or 7.0 Fr and lot codes listed in the recall notice. The sets have an AQ Hydrophilic Coating and specific catalog numbers.
- Brand
Cook- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide Foreign: Australia Canada Austria Belgium Denmark Germany Spain Finland France Martinique French Polynesia Switzerland Ireland Italy Netherlands Poland Sweden United Kingdom Hong Kong New Zealand Chile Colombia Israel Russian Federation Czech Republic Greece Jordan Slovakia South Africa United Arab Emirates Slovenia Lithuania Morocco Romania Qatar Bulgaria Libya Saudi Arabia Turkey Ukraine Thailand
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1369-2019 | 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 AQ-003600 G17151; 7.0 Fr AQ-003700 G17152; All lot codes | 12968 |
| Z-1370-2019 | 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; All lot codes | 3711 |
What to do — step by step
Check Product Label
Look for the product size (4.7 Fr, 6.0 Fr, or 7.0 Fr) and lot code on the stent set packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: Australia Canada Austria Belgium Denmark Germany Spain Finland France Martinique French Polynesia Switzerland Ireland Italy Netherlands Poland Sweden United Kingdom Hong Kong New Zealand Chile Colombia Israel Russian…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1369-2019 (April 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1369-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.