Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
Class I - Dangerous 🏥 Medical Devices
Recalled: April 22, 2020 LABORIE MEDICAL TECHNOLOGIES, CANADA ULC Diagnostic Equipment
Nationwide
What Should You Do?
- Check if you have this product: Model Number: REF 902101226, LOT 15883/1
- 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:
- LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
- Reason for Recall:
- This field correction is being initiated to address potentially damaged seals in the packaging of some the Laborie Pump Tube Sets. Finished goods inventory was detected with damage to their seals in the form of breaches or folds. Based on our investigation the issue appears to be limited to a single lot of part number 902101226 pump tubing sets.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
Product Codes/Lot Numbers:
Model Number: REF 902101226, LOT 15883/1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2535-2020