Laser atherectomy catheter recalled for sterile barrier packaging defects
Northeast Scientific is recalling NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheters due to potential breaches in sterile barrier packaging. A total of 616 units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile medical device with potential for sterile barrier breach that could compromise sterility assurance. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Northeast Scientific Inc. is recalling the NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter, Model Number R-417-156. This device is used to treat narrowed or blocked blood vessels in the legs through a procedure called atherectomy.
The recall was issued due to potential for breaches in the sterile barrier packaging that could compromise sterility assurance. All lot numbers within their labeled shelf life with expiration dates prior to August 29, 2026 are affected.
A total of 616 units were distributed nationwide to 17 states: California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas, and Virginia.
The recalled product
- Product
- NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
- Manufacturer
- Northeast Scientific Inc.
- Hazard
- sterile-barrier-breach
- contamination-risk
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 (2)
- Model No R-417-156
- UDI-DI 00850044399109
Distribution
Distributed nationwide across the United States.
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