Reported Jul 15, 2020 · Terminated
Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic…
Laborie Medical Technologies, Canada Ulc
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LABORIE MEDICAL TECHNOLOGIES, CANADA ULC · 6415 Northwest Dr Unit 11 · Mississauga · N/A
Is this the product you have?
- Pump Tube Set for MMS
- Libra and Solar Systems - Product UsageIntended 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
- Lot codes and dates
- Model Number
REF 902101226LOT 15883/1
- Model Number
- Amount recalled
- 480 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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