CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539. Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540. Catalog No. 46026: D35572; D39583.
- 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:
- Medtronic Neurosurgery
- Reason for Recall:
- Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.
Product Codes/Lot Numbers:
Lot Numbers: Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539. Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540. Catalog No. 46026: D35572; D39583.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0397-2014
Related Recalls
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Potential for catheter disconnection from the patient line stopcock connectors.