Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, …
Official notice from a government agency or its published feed.
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
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.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
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.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
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…
View the FDA enforcement report ↗ ← All reports