Laborie Pump Tube Sets Recalled for Damaged Packaging Seals
Laborie Medical Technologies is recalling 480 Pump Tube Sets due to damaged packaging seals that may compromise product integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging defect (damaged seals) without reporting any illnesses, injuries, or specific clinical harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Laborie Medical Technologies, Canada ULC is recalling 480 units of Pump Tube Sets for MMS Libra and Solar Systems. The recall addresses potentially damaged seals in the packaging, which were found to have breaches or folds. The issue appears to be limited to a single lot (LOT 15883/1) of part number 902101226.
These products are intended for use during water perfusion urodynamic procedures to study bladder and urethra function. The affected units were distributed nationwide in the United States, including in Colorado, Florida, Indiana, Michigan, New Jersey, New York, Ohio, Oregon, Pennsylvania, and Texas.
The FDA has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
- Category
- Medical Device — Urological
- Hazard
- Affected units
- 480
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number: REF 902101226
- LOT 15883/1
Distribution
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