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BIOTRANS™ Pressure Monitoring Kits
BIOPTIMAL INTERNATIONAL PTE. LTD. · Model LS2 ADD-ON KIT-USA · UDI-DI 08888893313832
DRS
Prescription
10
510(k) clearances
3,904
Adverse events (25 deaths)
236
Recalls
86
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-24 | Medline Industries, LP | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-24 | Medline Industries, LP | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2025-02-12 | MEDLINE INDUSTRIES, LP - Northfield | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad |
| 2023-11-10 | Smiths Medical Asd Inc | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad |
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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.