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Filter, Infusion Line
FDA product code FPB · Class 2 · General Hospital
135
Registered devices
1,174
Adverse events
8
Recalls
99
510(k) clearances
Devices with this code
Medex — ICU MEDICAL, INC.Medex — ICU MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.INTERLINK — BAXTER INTERNATIONAL INC.Medex — ICU MEDICAL, INC.WalkMed® — WALKMED TECHNOLOGIES, LLCGRI-BAG — LABORATORIOS GRIFOLS SAEXTENSION SET — BAXTER HEALTHCARE CORPORATIONMedex — ICU MEDICAL, INC.Medex — ICU MEDICAL, INC.VYGON — Vygon CorporationPall Posidyne® ELD Filter — Global Life Sciences Solutions USA LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medex — ICU MEDICAL, INC.Medex — ICU MEDICAL, INC.Pall Supor® 1.2 Filter — Global Life Sciences Solutions USA LLCMedex — ICU MEDICAL, INC.VYGON — Vygon CorporationMedex — ICU MEDICAL, INC.Pall Posidyne® NEO Filter — Global Life Sciences Solutions USA LLCVYGON — Vygon CorporationMedex — ICU MEDICAL, INC.Medex — ICU MEDICAL, INC.Spectrum, Inc. — SPECTRUM, INC.
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 |
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