CLASS I Drug recall · Reported 24 Sep 2014 · FDA Enforcement Report
0.9% Sodium Chloride Injection recalled by Baxter Healthcare
Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP, distributed nationwide in the US. The recall was initiated on 11 Jul 2014 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1591-2014
- FDA event ID
- 68728
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Sodium Chloride
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Jul 2014
- FDA classified
- 18 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Jul 2014 | Recall initiated by company | |
| 18 Sep 2014 | Classified by FDA | +69 days |
| 24 Sep 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Product as listed by the FDA
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Where it was distributed
Nationwide, Puerto Rico, Singapore, and Hong Kong
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Which lots are affected?
Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14
Where was it sold?
Nationwide, Puerto Rico, Singapore, and Hong Kong
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 68728This product is part of a recall event; the main page for the event is 0.9% Sodium Chloride Injection USP Mini-bag Plus Container recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | 0.9% Sodium Chloride Injection USP Mini-bag Plus Container recalledSodium Chloride | Baxter Healthcare | Particulate Matter | Nationwide | |
| CLASS I | Potassium Chloride Injection recalled by Baxter HealthcarePotassium Chloride | Baxter Healthcare | Particulate Matter | Nationwide |
More recalls from Baxter Healthcare
All 578| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Likorall Overhead Lifts Product Code: 3121001 Product Description recalled | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
Other Sodium Chloride recalls
All 133| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide |