# FDA recall Z-2535-2020

> **LABORIE MEDICAL TECHNOLOGIES, CANADA ULC** · Class II · device recall initiated 2020-04-22.

## 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.

## 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

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

## Key facts

- **Recall number:** Z-2535-2020
- **Recalling firm:** LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-22
- **Report date:** 2020-07-15
- **Termination date:** 2021-04-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mississauga, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2535-2020

## Citation

> AI Analytics. FDA recall Z-2535-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2535-2020. Source: US FDA. Licensed CC0.

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