Medtronic recalls Visualase Cooled Laser Applicator System Tubing Sets with specific product numbers and lot ranges due to potential saline flow disruption from incorrect fittings or adhesive.
The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.
Medtronic is recalling Visualase Cooled Laser Applicator System Tubing Sets that may have incorrect Luer connectors, drip chambers, or excessive adhesive. This could block saline flow during medical procedures, risking procedure failure or complications.
The tubing may have incorrect Luer connector assembly, drip-chamber assembly, or too much adhesive. This can cause the tubing to block, preventing proper saline flow during medical procedures.
Patients undergoing medical procedures using these specific tubing kits are affected. Healthcare providers using the recalled kits for laser surgery are most at risk.
Check for product numbers VCLAS 9735559, 9735560, or 9735561 with lot numbers from 0211041602 through 0217695790. These kits are used in laser surgery procedures.
Identify if your kit has product numbers VCLAS 9735559, 9735560, or 9735561 with lot numbers in the specified range.
The tubing may have incorrect Luer connector assembly, drip-chamber assembly, or excessive adhesive causing blockage, which could disrupt saline flow during medical procedures.
Check for product numbers VCLAS 9735559, 9735560, or 9735561 with lot numbers from 0211041602 through 0217695790.
No immediate stop is required; check your product numbers and lot numbers to determine if your kit is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1905-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1905-2020 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
