NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots L0017886 through L0020553
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Northeast Scientific Inc.
- Reason for Recall:
- 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Product Codes/Lot Numbers:
Lots L0017886 through L0020553
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2334-2021
Related Recalls
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Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.