Recalls / Class II
Class IID-0549-2018
Product
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Irrigation
- NDC
- 0264-2201
- FDA application
- NDA016733
- Affected lot / code info
- Batch # J7N912, Exp 10/31/20
Why it was recalled
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 McGaw Ave, N/A, Irvine, California 92614-5841
Distribution
- Quantity
- 17,360 plastic irrigation containers
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-02-16
- FDA classified
- 2018-02-27
- Posted by FDA
- 2018-03-07
- Terminated
- 2020-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0549-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.