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Pall Posidyne® NEO Filter

Global Life Sciences Solutions USA LLC · Model NEO96NY · UDI-DI 00636207300935

FPB Prescription

510(k) clearances

1,167

Adverse events (3 deaths)

Recalls

Facilities

Description

Small volume 0.2 micron Air Eliminating Intravenous Filter for 96 Hour Use with Needle-free Injection Site and ultra-microbore tubing

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 incomplete welds. Th
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 within the window of
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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Data 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.