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LABORIE MEDICAL TECHNOLOGIES, CANADA ULC recalls Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic proced
Recalled July 15, 2020 · FDA recall Z-2535-2020 · LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
Hazard
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. · FDA Class II
Units
480 units
Sold at
US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX.
Description
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.
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.
Manufacturer(s)
LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →