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MEDIMAX TECH INC. · Model PSF2 · UDI-DI 00817325023764
NKC
Prescription
0
510(k) clearances
52
Adverse events
3
Recalls
94
Facilities
Description
PSF2: Laparoscopic Smoke Evacuation, Passive type, Filter and Fluid Trap - (1 pc per pack/ 10 pcs per box)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-09 | Karl Storz Endoscopy | The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level. |
| 2017-10-10 | Karl Storz Endoscopy | The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product. |
| 2013-07-15 | DeRoyal Industries Inc | DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which |
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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.