0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
US0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall / Hazard
TranslatedLack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product Description & Identification
Translated0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Additional Source Details
| Field | Value |
|---|---|
| City | Allentown |
| State | PA |
| Openfda › Unii | 451W47IQ8X |
| Openfda › Route | IRRIGATION |
| Openfda › Rxcui | 486515 |
| Openfda › Spl id | 69f7d8f6-65cd-45bd-83f7-7249905a2e72 |
| Openfda › Brand name | SODIUM CHLORIDE FOR IRRIGATION |
| Openfda › Spl set id | 5bd9b176-0402-4a3f-a6b4-c3f393fc092a |
| Openfda › Package ndc › 1 | 0264-7388-50 |
| Openfda › Package ndc › 2 | 0264-7388-60 |
| Openfda › Product ndc | 0264-7388 |
| Openfda › Generic name | SODIUM CHLORIDE FOR IRRIGATION |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | SODIUM CHLORIDE |
| Openfda › Manufacturer name | B. Braun Medical Inc. |
| Openfda › Application number | NDA016733 |
| Openfda › Is original packager | true |
| Event id | 98693 |
| Address 1 | 861 Marcon Blvd |
| Address 2 | N/A |
| Code info | Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028. |
| Postal code | 18109-9577 |
| Report date | 20260429 |
| Product type | Drugs |
| Product quantity | 124,244 bags |
| Reason for recall | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260402 |
| Initial firm notification | Letter |
| Center classification date | 20260428 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-352...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmB BRAUN MEDICAL INC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: B BRAUN MEDICAL INC - 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60. Check if your household is affected: https://therecallfile.com/recalls/0-9-sodium-chloride-irrigation-usp-3000-ml-bags-rx-only-sterile-b-brau/FDA-D-0497-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Related Recalls
FDA DrugsLevothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Subpotent Drug
FDA DrugsRamipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
FDA DrugsLevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
Subpotent Drug