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GRI-BAG

LABORATORIOS GRIFOLS SA · Model 1000 AP · UDI-DI 08426314580816

NEP FPB KPE Prescription

510(k) clearances

1,226

Adverse events (7 deaths)

Recalls

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
2026-04-22	Baxter Healthcare Corporation	Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slow
2026-03-25	Omnicell, Inc.	Potential for mislabeled syringe produced by the i.v.STATION device.
2023-03-27	OmniCell, Inc.	IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product lab
2022-06-22	Baxter Healthcare Corporation	There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
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
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
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an
2018-06-04	B. Braun Medical, Inc.	There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there i

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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.