Recalls / Class II
Class IID-1282-2014
Product
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Irrigation
- NDC
- 0338-0048
- FDA application
- NDA017427
- Affected lot / code info
- Lot # Gl09272; Exp 09/16
Why it was recalled
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 211,752 bottles
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2014-04-21
- FDA classified
- 2014-04-28
- Posted by FDA
- 2014-05-07
- Terminated
- 2015-02-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1282-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.