Home › Device types › FPB
Filter, Infusion Line
FDA product code FPB · Class 2 · General Hospital
135
Registered devices
1,167
Adverse events
8
Recalls
98
510(k) clearances
Devices with this code
Medex — ICU MEDICAL, INC.VYGON — Vygon CorporationMedex — ICU MEDICAL, INC.VYGON — Vygon CorporationPall Supor® 1.2 Filter — Global Life Sciences Solutions USA LLCGRI-BAG — LABORATORIOS GRIFOLS SAMedex — ICU MEDICAL, INC.WalkMed® — WALKMED TECHNOLOGIES, LLCMedex — ICU MEDICAL, INC.Medex — ICU MEDICAL, INC.Pall Posidyne® NEO Filter — Global Life Sciences Solutions USA LLCSpectrum, Inc. — SPECTRUM, INC.Medex — ICU MEDICAL, INC.Medex — ICU MEDICAL, INC.EXTENSION SET — BAXTER HEALTHCARE CORPORATIONPall Supor® AEF Filter — Pall International SàrlMedex — ICU MEDICAL, INC.VYGON — Vygon CorporationHEMO-TAP — UTAH MEDICAL PRODUCTS, INC.INTERLINK — BAXTER INTERNATIONAL INC.VYGON — Vygon CorporationGRI-BAG — LABORATORIOS GRIFOLS SAMedex — ICU MEDICAL, INC.VYGON — Vygon Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-31 | Smiths Medical ASD Inc. | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or |
| 2017-12-13 | Halyard Health, Inc | The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible w |
| 2011-06-15 | Pall Life Sciences Puerto Rico Llc | Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the TNA1 filter used with total parenteral nutrition mixtures. |
| 2004-01-26 | Millipore Corp. | Lack of assurance of sterility |
| 2004-01-26 | Millipore Corp. | Lack of assurance of sterility |
| 2004-01-26 | Millipore Corp. | Lack of assurance of sterility |
| 2004-01-26 | Millipore Corp. | Lack of assurance of sterility |
| 2004-01-26 | Millipore Corp. | Lack of assurance of sterility |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.