Recalls / Class II
Class IID-0517-2020
Product
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Irrigation
- NDC
- 0338-0047
- FDA application
- NDA017867
- Affected lot / code info
- Lot #: Y309971, Y309971A, Exp. date 6/30/2021
Why it was recalled
Lack of Assurance of Sterility: Product has the potential to leak.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 22336 bags
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-11-19
- FDA classified
- 2019-11-20
- Posted by FDA
- 2019-11-27
- Terminated
- 2021-02-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0517-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.