CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report
Medical Kwart Retro-Inject Ureteral Stent Set 7.. 22- -Used recalled
Cook is recalling Medical Kwart Retro-Inject Ureteral Stent Set 7.. 22- -Used for retrograde injection, distributed in Florida, Kentucky, Maryland, New York, Pennsylvania, Texas. The recall was initiated on 4 Jan 2021 and the FDA has classified it as Class II.
Check your package
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-0960-2021
- FDA event ID
- 87087
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jan 2021
- FDA classified
- 5 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- Heart & Vascular Devices
Timeline
| 4 Jan 2021 | Recall initiated by company | |
| 5 Feb 2021 | Classified by FDA | +32 days |
| 17 Feb 2021 | 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
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
Where it was distributed
FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
Questions about this recall
Why was it recalled?
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Which lots are affected?
Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897
Where was it sold?
FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
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 26 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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