Z-2535-2020Class II

Pump Tube Set for MMS Libra and Solar Systems -

Name: Z-2535-2020 Pump Tube Set for MMS Libra and Solar Systems -
Creator: Laborie Medical Technologies, Canada Ulc
Published: 2020-04-22
License: https://open.fda.gov/license/

Laborie Medical Technologies, Canada ULC / initiated 2020-04-22 / Terminated / root cause: packaging

FDA source

LABORIE MEDICAL TECHNOLOGIES, CANADA ULC began a recall of 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... on 2020-04-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2535-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-22
Posted: 2020-07-08
Terminated: 2021-04-25
Recalling firm: Laborie Medical Technologies, Canada ULC
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.
Product code: FEZ Catheter And Tube, Suprapubic
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.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 480 units
Distribution: US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX.
Product codes and lots: Model Number: REF 902101226, LOT 15883/1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2535-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2535-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-08

Product code FEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)