Pump Tube Set for MMS Libra and Solar Systems — Class II medical device recall Z-2535-2020
Terminated recall by LABORIE MEDICAL TECHNOLOGIES, CANADA ULC, reported 2020-07-15, distributed nationwide. This field correction is being initiated to address potentially damaged seals in the packaging of some the Lab
| Recall number | Z-2535-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LABORIE MEDICAL TECHNOLOGIES, CANADA ULC, Mississauga, Canada |
| Recall initiated | 2020-04-22 |
| Classified | 2020-07-08 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-04-25 |
| Distributed | Nationwide (US) |
| Quantity | 480 units |
| Lot numbers | 15883/1 |
| Model numbers | 902101226 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2535-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.