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GRI-BAG
LABORATORIOS GRIFOLS SA · Model 500 AP · UDI-DI 08426314580823
1
510(k) clearances
6,755
Adverse events (8 deaths)
62
Recalls
85
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 |
|---|---|---|
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
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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.