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PSDS Bicarb Systems
MAR COR PURIFICATION, INC. · Model PSDS,2 ACID,1 BICARB · UDI-DI 00817492021099
FIN
Prescription
10
510(k) clearances
5
Adverse events
4
Recalls
5
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-28 | Isopure Corp | Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device compone |
| 2019-04-19 | Isopure Corp | There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use |
| 2012-03-26 | Tango3 LLC | During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either n |
| 2006-11-12 | Hill-Rom, Inc. | False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handl |
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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.