Laborie Medical recalls pump tube sets for MMS Libra and Solar systems due to potential packaging seal damage in a specific lot. Affected units may have compromised seals that could lead to improper use during urodynamic procedures.
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.
Laborie Medical is recalling pump tube sets for MMS Lib: Libra and Solar systems because some units have damaged packaging seals. This could lead to improper use during urodynamic procedures if the tubes are not properly sealed.
Damaged packaging seals in the specific lot could lead to improper tube function during urodynamic procedures. However, the issue is limited to packaging and does not affect the tube's internal components.
Healthcare professionals using Laborie pump tube sets for urodynamic procedures are most at risk. The recall affects specific units with lot number 15883/1.
Check for model number REF 902101226 and lot number 15883/1 on the packaging. The recall applies only to a single lot of pump tubing sets.
Look for model number REF 902101226 and lot number 15883/1 on the packaging.
Laborie Medical is recalling pump tube sets for MMS Libra and Solar systems due to potential packaging seal damage in a specific lot.
Check for model number REF 902101226 and lot number 15883/1 on the packaging. The recall applies only to this specific lot.
No, the recall does not require stopping use. The issue is limited to packaging and does not affect the tube's internal components.
We’ve drafted a message you can send Laborie Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2535-2020 — Laborie Medical Laborie Medical Hello, I own a Laborie Medical that is covered by recall Z-2535-2020 from Laborie Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
