Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Northeast Scientific Inc. or your healthcare provider for instructions. Notification method: Letter
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. 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 cleared for marketing in the US.. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.. Classification: Class II. Quantity: 795 units. Distribution: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Glenmark Pharmaceuticals Inc. recalled 13,824 tubes of Azelaic Acid Gel on September 17, 2025. The recall stems from market complaints regarding a gritty texture. Consumers should stop using the product immediately and contact their healthcare provider.