Reported May 13, 2020 · Terminated
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS…
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- Visualase Cooled Laser Applicator
- System Tubing Set kits Product numbers
VCLAS 97355593mm tip/1.65mm catheter VCLAS 973556010mm tip/1.65mm catheter VCLAS 973556115mm tip/1.85mm catheter
- Lot codes and dates
- All kits with lot numbers from 0211041602 through 0217695790
- Amount recalled
- 4654 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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