Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx...
FDA Recall #D-1275-2014 — Class I — November 21, 2013
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.
Recalling Firm
B. Braun Medical Inc — Irvine, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
5,592 units
Distribution
Nationwide, Puerto Rico and Spain
Code Information
Lot# J3B007, Exp 08/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated