Recalls / Class I
Class ID-1270-2014
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, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55
- Affected lot / code info
- Lot# J0B003, 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
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 McGaw Ave, Irvine, California 92614-5841
Distribution
- Quantity
- 1302 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-1270-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.