CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report
Pump Tube Set for MMS Libra and Solar Systems recalled
Laborie Medical Technologies, Canada ULC is recalling Pump Tube Set for MMS Libra and Solar Systems, distributed nationwide in the US. The recall was initiated on 22 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2535-2020
- FDA event ID
- 85655
- Recalling firm
- Laborie Medical Technologies, Canada ULC, Mississauga
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2020
- FDA classified
- 8 Jul 2020
- Reported
- 15 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Patient Monitors
Timeline
| 22 Apr 2020 | Recall initiated by company | |
| 8 Jul 2020 | Classified by FDA | +77 days |
| 15 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX.
Nationwide ColoradoFloridaIndianaMichiganNew JerseyNew YorkOhioOregonPennsylvaniaTexas
Questions about this recall
Why was it 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.
Which lots are affected?
Model Number: REF 902101226, LOT 15883/1
Where was it sold?
US Nationwide distribution including in the states of CO, FL, IN, MI, NJ, NY, OH, OR, PA and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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