NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Tu
FDA device recall Z-0022-2026 · posted 2025-10-02 · Open, Classified
Recall details
- Recalling firm
- Northeast Scientific Inc.
- Reason for recall
- Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
- Action taken
- Northeast Scientific notified consignees via an "URGENT: Medical Device Recall Notification" letter dated 8/29/2025 and email. Consignees were instructed to immediately discontinue use of affected products, quarantine and return any unused affected units, and complete and return the enclosed Recall Response Form, even if you no longer have any affected product. If product were further distributed, consignees were instructed to notify those customers immediately and ensure they also discontinue use and return the devices. Northeast Scientific will provide replacement product (if available) or credit for returned product. In addition, Northeast Scientific has initiated an investigation and is implementing corrective actions to prevent recurrence. If you have any questions or concerns, please reach out to your Northeast Scientific Sales Representative or contact us at Sales@nescientific.com or 203-756-2111.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- QTF
- Quantity affected
- 795 units
- Distribution
- US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
- Date initiated
- 2025-08-29
- Date posted
- 2025-10-02
- Location
- Waterbury, CT
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