Cook Incorporated — Class II: Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, b
Cook Incorporated is recalling specific lots of Williams Cystoscopic Injection Needles due to manufacturing errors where female Luer lock adapters were not correctly seated because of misalignment and inadequate torquing.
Cook Incorporated, clinical personnel performing cystoscopic injections, and medical device manufacturing teams responsible for mechanical assembly and torque validation.
This recall highlights the criticality of process controls during the assembly of multi-component devices. Inadequate seating of adapters could lead to fluid leaks or mechanical failure during procedures, potentially resulting in sub-optimal treatment delivery or increased procedural time. Regulatory teams should view this as a failure in manufacturing quality control.
Verify that manufacturing assembly protocols for luer-connected components include validated torque specifications and alignment checks. QA teams should review complaint logs for reports of assembly failure or procedural delays that might indicate underlying manufacturing deviations.
Class II. Reason: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.. Product: Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112. Firm: Cook Incorporated (Bloomington IN United States). Status: Ongoing.
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