Recall archive / FDA drug enforcement

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7... — FDA record D-0655-2022

Reported terminated

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 Feb 25, 2022. 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, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Reason: Lack of sterility assurance: leaking bags
Classification: Class II
Recalling firm: B. Braun Medical, Inc.
Quantity: 33,742 bags
Agency-reported status: Terminated
Source record identifier: D-0655-2022

Open the official record

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

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #: J1E086, J1E204, J1E213, Exp 5/31/2023; J1H137, J1H138, Exp 6/30/2023

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

Distribution

USA Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 23, 2022
Recall initiation date: Feb 25, 2022
Center classification date: Mar 17, 2022
Termination date: Mar 16, 2023

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.