LABORIE MEDICAL TECHNOLOGIES, CANADA ULC: Medical Device Recall in 2020 - (Recall #: Z-2535-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 22, 2020

Date Posted: July 15, 2020

Recall Number: Z-2535-2020

Event ID: 85655

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.

Status: Terminated

Product Quantity: 480 units

Code Information:

Model Number: REF 902101226, LOT 15883/1

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated