Sodium Chloride for Irrigation Lacks Sterility Assurance
B. Braun Medical Inc. is recalling sodium chloride for irrigation solution (3000 mL bags) due to lack of assurance of sterility and potential leakage from the diaphragm port. Affected lots distributed nationwide have expiration dates through May 31, 2028.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile irrigation solution with confirmed defects (lack of sterility assurance and potential leakage). A compromised sterile product with loss of aseptic integrity poses risk of serious infection in medical irrigation applications. Class II recalls with risk of serious health consequences warrant Severe (4) classification.
Plain-English summary
B. Braun Medical Inc. is recalling 124,244 bags of 0.9% Sodium Chloride for Irrigation, USP, in 3000 mL bags (Rx only, NDC 0264-7388-60) distributed nationwide. The product lacks assurance of sterility and may leak from the diaphragm port once the foil is removed.
The affected lots are J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239 (expiration 30 April 2028), J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248 (expiration 30 April 2028), and J5H151, J5H152, J5H153, J5H154, J5H155 (expiration 31 May 2028). The product is manufactured by B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA.
Healthcare providers and patients who have received or are using this product should stop use immediately. For more information, contact the FDA or B. Braun Medical Inc.
The recalled product
- Product
- SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
- Brand
- SODIUM CHLORIDE FOR IRRIGATION
- Manufacturer
- B BRAUN MEDICAL INC
- Hazard
- lack-of-sterility
- leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot # J5E226
- J5E227
- J5E228
- J5E229
- J5E230
- J5E231
- J5E232
- J5E233
- J5E238
- J5E239
- Exp Date: 30Apr2028
- Lot # J5E240
- J5E241
- J5E242
- J5E243
- J5E244
- J5E245
- J5E247
- J5E248
- Lot # J5H151
Distribution
Distributed nationwide across the United States.