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GRI-BAG
LABORATORIOS GRIFOLS SA · Model 250 · UDI-DI 08426314604031
1
510(k) clearances
1,167
Adverse events (3 deaths)
8
Recalls
51
Facilities
Description
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAG AP models have a conus vial output connector.
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.
