0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corp... — FDA record D-0849-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 17, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
Reason
Presence of particulate matter: Particulates identified as fiberglass
Classification
Class I
Recalling firm
Baxter Healthcare Corporation
Quantity
145,464 500mL bags
Agency-reported status
Ongoing
Source record identifier
D-0849-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot: Y495523, Y495523A, Exp 31-Oct-2027

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Natonwide in the USA

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date
Sep 9, 2026
Recall initiation date
Aug 17, 2026
Center classification date
Sep 15, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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