CLASS II Drug recall · Reported 19 Jul 2017 · FDA Enforcement Report
0.9% Sodium Chloride Injection, USP Viaflex Container recalled
Baxter Healthcare is recalling 0.9% Sodium Chloride Injection, USP Viaflex Container, distributed nationwide in the US. The recall was initiated on 6 Jul 2017 and the FDA has classified it as Class II.
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-0973-2017
- FDA event ID
- 77676
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Sodium Chloride
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jul 2017
- FDA classified
- 11 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Jul 2017 | Recall initiated by company | |
| 11 Jul 2017 | Classified by FDA | +5 days |
| 19 Jul 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Bags have the potential to leak.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38
Where it was distributed
Nationwide, Puerto Rico and Saudi Arabia
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Bags have the potential to leak.
Which lots are affected?
Lots: P361501, P361667, and P361790, Exp 09/30/18
Where was it sold?
Nationwide, Puerto Rico and Saudi Arabia
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
1 other product · FDA event 77676This product is part of a recall event; the main page for the event is 5% Dextrose Injection, USP Viaflex recalled by Baxter Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 5% Dextrose Injection, USP Viaflex recalled by Baxter HealthcareDextrose | Baxter Healthcare | Sterility | Nationwide |
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | 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 |