Use caution Drug recall · FDA · Published February 10, 2023

B. Braun Medical Recalls 500mL IV Fluid Due to Possible Leakage Risk

B. Braun Medical is recalling certain batches of 0.9% Sodium Chloride Injection for possible leakage due to incomplete seals. Affected lots have specific expiration dates and may exhibit microscopic channel leaks near the port assembly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0347-2023Drug B. Braun Medical ›

Use caution until it’s fixed

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.

Take action

Contact the company

Recalling firmB. Braun Medical Inc.1845 Mason Ave · Daytona Beach, FL 32117-5102

✎ GovInfoNow plain-language explainer

B. Braun Medical is recalling specific batches of 500mL IV saline containers because they may have incomplete seals that could cause leakage. This poses a risk of contamination if the container leaks, especially in medical settings where sterile solutions are critical. Read more at govinfonow.com/recall/33880-b-braun-medical-recalls-500ml-iv-fluid-due-to-possible.

Source Summary by GovInfoNow · govinfonow.com/recall/33880-b-braun-medical-recalls-500ml-iv-fluid-due-to-possible · Updated August 18, 2026 · FDA enforcement record: FDA #D-0347-2023

Cite this page

“B. Braun Medical Recalls 500mL IV Fluid Due to Possible Leakage Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33880-b-braun-medical-recalls-500ml-iv-fluid-due-to-possible. Based on FDA recall #D-0347-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0347-2023%22&limit=1).

The FDA announced on Feb. 10, 2023, that B. Braun Medical Inc. is recalling 483,229 bags of 0.9% Sodium Chloride Injection, USP, due to a lack of sterility assurance from incomplete seals. The agency said the recall affects specific lots distributed nationwide.

How to tell if you have it

Brand: B. Braun Medical
Product: 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only
NDC: 0264-5802-10
Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024
Quantity: 483,229 bags

The hazard

The FDA said the recall is due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.

Context

GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since 2013-10-15. Other recent recalls include a 2026-08-19 recall of B. Braun Medical 100mL Sodium Chloride Injection for particulate matter and a 2026-08-12 recall of B. Braun Medical Lactated Ringer's Injection for particulate matter. Other recent recalls of similar products include an Otsuka ICU Medical 100mL IV Fluid Recall (2025-10-27) and Keystone Burkhart Anesthetic Gel and Keystone Pearson Topical Anesthetic Gel recalls (both 2026-05-21).

How to tell if you have this one

Check for the specific expiration dates: 01/31/2024, 02/29/2024, 03/31/2024, or 04/30/2024. The product is a 500mL IV container labeled as 0.9% Sodium Chloride Injection, USP, Rx Only.

Brand
B. Braun Medical
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Completed
Distribution
USA Nationwide.

Recall number	Product, codes & lots	Quantity	NDC
D-0346-2023	0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00; Lots: 0061786962 Exp. 11/30/2023; 0061797767 Exp. 04/30/2024; 0061797768 Exp. 05/31/2024; 0061787769 Exp. 05/31/2024; 0061797770 Exp. 05/31/2024; 0061797771 Exp. 05/31/2024; 0061797772 Exp. 05/31/2024; 0061797773 Exp. 05/31/2024; 0061797774 Exp. 05/31/2024; 0061797775 Exp. 05/31/2024; 0061797776 Exp. 05/31/2024; 0061812946 Exp. 05/31/2024; 0061812947 Exp. 05/31/2024; 0061812948 Exp. 05/31/2024; 0061812949 Exp. 05/31/2024; 0061812950 Exp. 05/31/2024; 0061816017 Exp. 06/30/2024; 0061816018 Exp. 06/30/2024; 0061816019 Exp. 06/30/2024; 0061816020 Exp. 06/30/2024; 0061816021 Exp. 06/30/2024; 0061816358 Exp. 06/30/2024; 0061816359 Exp. 06/30/2024; 0061816361 Exp. 07/31/2024; 0061816362 Exp. 07/31/2024; 0061816363 Exp. 07/31/2024; 0061816364 Exp. 07/31/2024; 0061818516 Exp. 07/31/2024; 0061818517 Exp. 07/31/2024; 0061818518 Exp. 07/31/2024; 0061821562 Exp. 08/31/2024; 0061821563 Exp. 08/31/2024; 0061821564 Exp. 08/31/2024; 0061823709 Exp. 08/31/2024; 0061823710 Exp. 08/31/2024; 0061823711 Exp. 08/31/2024; 0061823714 Exp. 08/31/2024; 0061823715 Exp. 08/31/2024; 0061823716 Exp. 08/31/2024; 0061824770 Exp. 08/31/2024; 0061824771 Exp. 08/31/2024; 0061824772 Exp. 08/31/2024; 0061824773 Exp. 08/31/2024; 0061824774 Exp. 08/31/2024; 0061824775 Exp. 08/31/2024; 0061824776 Exp. 08/31/2024; 0061824777 Exp. 08/31/2024; 0061826486 Exp. 08/31/2024; 0061826487 Exp. 08/31/2024; 0061826488 Exp. 08/31/2024	1,343,982 bags	0264-5802-00, 0264-5802-10, 0264-5804-00, 0061786962, 0061797767, 0061797768, 0061787769, 0061797770, 0061797771, 0061797772, 0061797773, 0061797774, 0061797775, 0061797776, 0061812946, 0061812947, 0061812948, 0061812949, 0061812950, 0061816017, 0061816018, 0061816019, 0061816020, 0061816021, 0061816358, 0061816359, 0061816361, 0061816362, 0061816363, 0061816364, 0061818516, 0061818517, 0061818518, 0061821562, 0061821563, 0061821564, 0061823709, 0061823710, 0061823711, 0061823714, 0061823715, 0061823716, 0061824770, 0061824771, 0061824772, 0061824773, 0061824774, 0061824775, 0061824776, 0061824777, 0061826486, 0061826487, 0061826488
D-0347-2023	0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10; Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024	483,229 bags	0264-5802-00, 0264-5802-10, 0264-5804-00, 0061794230, 0061794232, 0061797779, 0061797780, 0061797781, 0061797783, 0061797784, 0061797785, 0061797786, 0061797787, 0061797788, 0061809680

Based on the official FDA remedy

What to do — step by step

Check Container Expiration
Verify the expiration date on the container to see if it matches the recalled lots listed in the notice.
Discontinue Use
If the container has an expiration date matching the recalled lots, stop using it immediately to prevent potential contamination.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 19 days after the firm started it.

Feb 10, 2023Firm started the recall
Feb 23, 2023FDA classified it Class II
Mar 1, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/33880-b-braun-medical-recalls-500ml-iv-fluid-due-to-possible">B. Braun Medical Recalls 500mL IV Fluid Due to Possible Leakage Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0347-2023 (February 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0347-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.