Cook Medical Kwart Retro-Inject Ureteral Stent Set Recalled for Material Defect
Cook Inc. is recalling 42 units of Kwart Retro-Inject Ureteral Stent Sets because they were manufactured with incorrect material, which may cause the stent to be stiffer and susceptible to degradation, breakage, or fragmentation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (breakage/fragmentation) in an implanted medical device, which meets the rubric criteria for a Severe rating.
Plain-English summary
Cook Inc. is recalling 42 units of the Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm (Reference Part Number 003700, GPN G14837). The affected lots are 13024536, 13089895, and NS13089897. These medical devices are used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and for leaving an indwelling ureteral stent.
The recall was initiated because the stents were manufactured with incorrect material. This defect may result in the stent being stiffer and potentially susceptible to degradation, which could potentially lead to breakage or fragmentation. The agency has classified this as a Class II recall.
The affected units were distributed in Florida, Kentucky, Maryland, New York, Pennsylvania, and Texas, as well as in Canada and Switzerland. Healthcare providers and patients who have received or used these specific stent sets should contact Cook Inc. or their medical provider for further instructions on replacement or removal.
The recalled product
- Product
- 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
- Manufacturer
- Cook Inc.
- Affected units
- 42
Distribution
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