Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Number Serial Number D134903 2519054 D134903 2534027 Note: Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer.
- 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:
- Stryker Sustainability Solutions
- Reason for Recall:
- Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Product Codes/Lot Numbers:
Item Number Serial Number D134903 2519054 D134903 2534027 Note: Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer.
Distribution:
Distributed in: US, KS
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0467-2019
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