Recall Z-2535-2020— LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
Class II · Terminated
Class II FDA medical device recall by LABORIE MEDICAL TECHNOLOGIES, CANADA ULC, initiated 2020-04-22, terminated 2021-04-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-22
- Terminated
- 2021-04-25
- Firm location
- Mississauga, Canada
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.