B BRAUN MEDICAL INC: LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- B BRAUN MEDICAL INC
- Product
- LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
- Reason / hazard
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2026-04-02
- Code info
- Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
- Product quantity
- 54,540 bags
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Allentown
- State
- PA
- Country
- United States
- Event id
- 98693
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