Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
| Brand name | LACTATED RINGERS IRRIGATION |
| Generic name | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE |
| Active ingredient(s) | CALCIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE |
| Distributed by / for | B BRAUN MEDICAL INC |
| NDC | 0264-7389-60 |
| Full product label | LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60. |
| Recalling firm | B BRAUN MEDICAL INC |
| Distribution | US Nationwide. |
| Quantity | 54,540 bags |
| Recall initiated | 2026-04-02 |
| Report date | 2026-04-29 |
| Recall completed | — |
| Recall number | D-0498-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Allentown PA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗