Recalls / Class I
Class ID-1265-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDC
- 0264-1800
- FDA application
- NDA017464
- Affected lot / code info
- Lot# J2P912, Exp 02/14
Why it was recalled
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
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 McGaw Ave, Irvine, California 92614-5841
Distribution
- Quantity
- 53,592 units
- Distribution pattern
- Nationwide, Puerto Rico and Spain
Timeline
- Recall initiated
- 2013-11-21
- FDA classified
- 2014-04-25
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1265-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.