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.
FDA Recall Z-2535-2020 · Posted None
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Recalling FirmLABORIE MEDICAL TECHNOLOGIES, CANADA ULC
Recall StatusTerminated
Product CodeFEZ
Date Initiated2020-04-22
Date Terminated2021-04-25
Product Quantity480 units
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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