CLASS II Drug recall · Reported 30 May 2018 · FDA Enforcement Report
0.9% Sodium Chloride Injection recalled by Fresenius Medical Care Renal
Fresenius Medical Care Renal Therapies Group is recalling 0.9% Sodium Chloride Injection, USP, distributed nationwide in the US. The recall was initiated on 13 Nov 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-0827-2018
- FDA event ID
- 79501
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Nov 2017
- FDA classified
- 22 May 2018
- Reported
- 30 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Nov 2017 | Recall initiated by company | |
| 22 May 2018 | Classified by FDA | +190 days |
| 30 May 2018 | 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
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, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # 17LU05005; Exp. 09/18 Part Number 060-10109
Where was it sold?
Product was distributed throughout the United States.
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.
More recalls from Fresenius Medical Care Renal Therapies Group
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|---|---|---|---|---|---|
| Device | CLASS II | CombiSet Hemodialysis Blood Tubing Set recalled | Fresenius Medical Care Renal Therapies Group | Other | Nationwide |
| Device | CLASS II | 5008X HD/HDF with CLiC Blood Tubing Set recalled | Fresenius Medical Care Renal Therapies Group | Packaging Defects | Nationwide |
| Device | CLASS II | 5008X HD/HDF Standard Blood Tubing Set recalled | Fresenius Medical Care Renal Therapies Group | Packaging Defects | Nationwide |
| Device | CLASS II | Citrasate, Liquid Acid Concentrate recalled | Fresenius Medical Care Renal Therapies Group | Other | Nationwide |
| Device | CLASS II | NaturaLyte, Liquid Acid Concentrate recalled | Fresenius Medical Care Renal Therapies Group | Other | 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 |