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Waters IGL Pulsatile Perfusion Solution
INSTITUT GEORGES LOPEZ · Model PPS/1000 · UDI-DI 13700911900614
KDL
Prescription
1
510(k) clearances
60
Adverse events (3 deaths)
4
Recalls
14
Facilities
Description
Clear, sterile, non-pyrogenic solution intended for the in-vitro flushing and temporary continuous perfusion preservation of explanted kidneys
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-09 | Dr Franz Koehler Chemie Gmbh | Potential for particles to be present in solution. |
| 2016-12-14 | Organ Recovery Systems, Inc. | Organ preservation fluid recalled due to potential for bacterial contamination. |
| 2016-10-12 | Baxter Healthcare Corp. | Potential presence of particulate matter on the blood side of the dialyzer |
| 2012-03-30 | Teva Pharmaceuticals USA, Inc. | Lack of assurance of sterility |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.