LABORIE MEDICAL TECHNOLOGIES, CANADA ULC recalls Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic proce…

Recall date

April 22, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2535-2020

FDA classification

Class II

Brand / firm

LABORIE MEDICAL TECHNOLOGIES, CANADA ULC

Sold / distributed

US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.