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Filter Needle for Single Use
Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · Model FN-B1838RW · UDI-DI 46975124930965
FPB
Prescription
1
510(k) clearances
1,174
Adverse events (3 deaths)
8
Recalls
51
Facilities
Description
The Filter Needle for Single Use consists of cap, needle cannula,needle hub, sheath and filter. This product is intended for the aspiration, filtration and preparation of medical fluid, not including injection.
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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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.