CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report

Kwart Retro-Inject Ureteral Stent Set: Product recalled by Cook

Cook is recalling Cook Kwart Retro-Inject Ureteral Stent Set: Product, distributed nationwide in the US. The recall was initiated on 22 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot codes

Quantity recalled12968

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1369-2019
FDA event ID: 82795
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2019
FDA classified: 17 May 2019
Reported: 29 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

22 Apr 2019	Recall initiated by company
17 May 2019	Classified by FDA	+25 days
29 May 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Is Kwart Retro-Inject Ureteral Stent Set: Product recalled?

Yes. Cook recalled Kwart Retro-Inject Ureteral Stent Set: Product on 22 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1369-2019.

Why was it recalled?

Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.

Which lots are affected?

All lot codes

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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