Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number FND-019-02 , Lot Number E1913645 ; UDI:( 01)00884450489369
- 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:
- Merit Medical Systems, Inc.
- Reason for Recall:
- The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.
Product Codes/Lot Numbers:
Catalog Number FND-019-02 , Lot Number E1913645 ; UDI:( 01)00884450489369
Distribution:
Distributed in: VA, NE, DC, MI, NY, KY, CA, TX, MD, AL, GA, UT, LA, CT, PA, WA, MT, NJ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1263-2021
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