FDA Recall D-1275-2014
B. Braun Medical Inc · Irvine, CA
Class I — life-threatening Terminated 378 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1275-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide, Puerto Rico and Spain
- Recall initiated
- 2013-11-21
- Classified by FDA Center
- 2014-04-25
- FDA published
- 2014-05-07
- Terminated
- 2014-12-04
- Recalling firm
- B. Braun Medical Inc
- Firm location
- Irvine, CA