Northeast Scientific Inc.: NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in

Hazard

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Details from the source

Reason for recall: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Distribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. Quantity: 1,019 units Lot/code info: Model No R-414-159; UDI-DI 00850044399123; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.

UPC codes

00850044399123

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.