Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
0.9% Sodium Chloride Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
Affected NDC
0264-5802-10
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Chloride NDC 00264-5802 |
.9 g/100mL | Injection, Solution Intravenous |
B. Braun Medical Inc. | Rx |
- Recalling firm
- B. Braun Medical Inc.
- NDC code
- 0264-5802-10
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0347-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by B. Braun Medical Inc.
All 2023 recalls
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate matter.
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate Matter.
Class II · Moderate risk
Lactated Ringer's Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Other sterility / contamination recalls from 2023
All sterility / contamination recalls
Class II · Moderate risk
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Lack of Sterility Assurance
Class II · Moderate risk
ceFAZolin sodium in Sterile Water for injection
Lack of assurance of sterility.
Class I · High risk
Up&Up brand dry eye relief
Non-Sterility
Class I · High risk
Rugby brand Lubricating Tears Eye Drops
Non-Sterility
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