Cook Medical Kwart Retro-Inject Ureteral Stent Set recall: Impurity Out of Spec
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy…
Why was Cook Medical Kwart Retro-Inject Ureteral Stent Set recalled?
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy…
- Recalling firm
- Cook Inc.
- Quantity
- 42 units
- Distribution
- FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
- Recall date
- February 17, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)