PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: May 7, 2014 Initiated: November 21, 2013 #D-1275-2014

Product 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

Reason for Recall

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Details

Recalling Firm
B. Braun Medical Inc
Units Affected
5,592 units
Distribution
Nationwide, Puerto Rico and Spain
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by B. Braun Medical Inc. Units affected: 5,592 units.
Why was this product recalled?
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 7, 2014. Severity: Critical. Recall number: D-1275-2014.