Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
Cook Incorporated is recalling 97 Williams Cystoscopic Injection Needles because a component may not be correctly seated, potentially causing inadequate treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source identifies a manufacturing defect where the Luer lock adapter may not be correctly seated, leading to potential inadequate treatment. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Cook Incorporated is recalling 97 units of Williams Cystoscopic Injection Needles, Reference Part Number 090001-S26, Order Number (GPN) G16112. The affected lots are 16613606, 16951548, and 16951548X. These devices are used for cystoscopic injection into the urethra, bladder neck, and bladder wall.
The recall was initiated because 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. This defect may result in increased procedural time and inadequate treatment.
The affected products were distributed in the US states of Florida, Illinois, New Mexico, Texas, and Washington, as well as in Canada, France, Germany, Italy, Spain, and Switzerland. Healthcare providers and facilities should stop using the affected devices and contact Cook Incorporated for further instructions.
The recalled product
- 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
- Manufacturer
- Cook Incorporated
- Affected units
- 97
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 00827002161122
- Lot Numbers: 16613606
- 16951548
- 16951548X
Distribution
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