C.R. Bard recalled 116 units of its InLay Optima Ureteral Stent Kit on November 6, 2025. A labeling discrepancy may cause the actual stent size to differ from the labeled size. Healthcare providers and patients should stop using the device immediately.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact C.R. Bard Inc or your healthcare provider for instructions. Notification method: Letter
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The BD InLay Optima Ureteral Stent Kit is used in urology to maintain the patency of the ureter. It is crucial for patients with urinary tract obstructions or those undergoing certain surgical procedures.
The risk arises from a labeling error that may lead to the use of the wrong size stent. This can result in complications during medical procedures, affecting patient safety.
This recall is not part of a broader industry pattern.
The recall affects a limited number of units, but immediate action is necessary to prevent potential complications.
The lot number is typically found on the box or label of the product packaging.
Expect a refund or replacement processing time of about 4-6 weeks.
Keep records of the product lot number, any correspondence with the manufacturer, and any medical records related to its use.
The recalled product is the BD InLay Optima Ureteral Stent Kit, size 6 Fr. x 30 cm, reference number 788630. The affected lot number is NGJU4327/UDI:(01)00801741015786. The product was distributed worldwide, including across several U.S. states and countries such as Canada and various European and Asian nations.
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