Recalls / Class II
Class IID-0112-2018
Product
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
- Brand name
- Acetic Acid
- Generic name
- Acetic Acid
- Active ingredient
- Acetic Acid
- Route
- Irrigation
- NDC
- 0264-2304
- FDA application
- NDA018161
- Affected lot / code info
- Lot #: J7N965, Exp. 10/31/2020
Why it was recalled
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
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
- 2,576 containers
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2017-12-15
- FDA classified
- 2017-12-20
- Posted by FDA
- 2017-12-27
- Terminated
- 2018-10-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0112-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.