Recall Z-2535-2020 ยท FEZ Catheter And Tube, Suprapubic
LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
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.
| Date | Apr 22, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 480 units |
| Distribution | US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.