CLASS II Drug recall · Reported 7 May 2014 · FDA Enforcement Report
0.9% Sodium Chloride Irrigation, USP,Not for Injection recalled
Baxter Healthcare is recalling 0.9% Sodium Chloride Irrigation, USP,Not for Injection, distributed nationwide in the US. The recall was initiated on 21 Apr 2014 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-1282-2014
- FDA event ID
- 67974
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Sodium Chloride
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Apr 2014
- FDA classified
- 28 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Apr 2014 | Recall initiated by company | |
| 28 Apr 2014 | Classified by FDA | +7 days |
| 7 May 2014 | Published in enforcement report | +9 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: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Product as listed by the FDA
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.
Where it was distributed
nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Which lots are affected?
Lot # Gl09272; Exp 09/16
Where was it sold?
nationwide
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.
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|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
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Other Sodium Chloride recalls
All 132| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | 0.9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride | Huons | Sterility | Nationwide |