Cook Inc.: Medical Device Recall in 2021 - (Recall #: Z-0960-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 4, 2021

Date Posted: February 17, 2021

Recall Number: Z-0960-2021

Event ID: 87087

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.

Status: Terminated

Product Quantity: 42 units

Code Information:

Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897

Distribution Pattern:

FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated