Z-2535-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- April 22, 2020
- Termination Date
- April 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 units
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.
Distribution Pattern
US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX.
Code Information
Model Number: REF 902101226, LOT 15883/1