Key Takeaway
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Sc by B. Braun Medical Inc was recalled on November 21, 2013. The hazard: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve samp...
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Sc
Description
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
Hazard / Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I: Dangerous or defective product that could cause serious health problems or death.
Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.
Products Affected
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Sc
DrugsCompany Information
B. Braun Medical Inc
Irvine, CA, United States
View all 38 recalls by B. Braun Medical Inc →Distribution
Nationwide, Puerto Rico and Spain
Related Recalls
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
August 26, 2025
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
August 26, 2025
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
August 18, 2025
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
August 18, 2025
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
August 4, 2025
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
August 4, 2025
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.