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U.S. Department of Health and Human Services

Class 2 Device Recall Pump Tube Set for MMS Libra and Solar Systems

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  Class 2 Device Recall Pump Tube Set for MMS Libra and Solar Systems see related information
Date Initiated by Firm April 22, 2020
Create Date July 08, 2020
Recall Status1 Terminated 3 on April 25, 2021
Recall Number Z-2535-2020
Recall Event ID 85655
Product Classification Catheter and tube, suprapubic - Product Code FEZ
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.
Code Information Model Number: REF 902101226, LOT 15883/1
Recalling Firm/
Manufacturer		 LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
6415 Northwest Dr Unit 11
Mississauga Canada
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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