FDA-Device2026-10-21Class IIPROCESSING DEFECT
Cook Williams Cystoscopic Injection Needles recalled for faulty Luer lock adapter
What this means
The female Luer lock adapter on certain Cook Williams Cystoscopic Injection Needles may not be properly attached due to a manufacturing error. This defect could cause the procedure to take longer or not work as intended.
- Check if your facility received affected lots: 16613606, 16951548, or 16951548X
- Stop using the device and contact Cook Incorporated for replacement or further instructions
- Review recent procedures performed with these devices to assess patient impact
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Affected count
97 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2027Want us to check the next one for you?
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