CLASS II Drug recall · Reported 27 Dec 2017 · FDA Enforcement Report
0.25% Acetic Acid Irrigation USP (PIC) recalled by B. Braun Medical
B. Braun Medical is recalling 0.25% Acetic Acid Irrigation USP (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, distributed nationwide in the US. The recall was initiated on 15 Dec 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-0112-2018
- FDA event ID
- 78767
- Recalling firm
- B. Braun Medical, Irvine, CA
- Brand
- Acetic Acid
- Manufacturer
- B. Braun Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Dec 2017
- FDA classified
- 20 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 15 Dec 2017 | Recall initiated by company | |
| 20 Dec 2017 | Classified by FDA | +5 days |
| 27 Dec 2017 | Published in enforcement report | +7 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: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Product as listed by the FDA
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Which lots are affected?
Lot #: J7N965, Exp. 10/31/2020
Where was it sold?
Product was distributed 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.
More recalls from B. Braun Medical
All 447| 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 |
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
Other Acetic Acid recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetic Acid Otic Solution recalled by Torrent Pharma | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS III | Acetic Acid Otic Solution recalled by Hi-Tech Pharmacal Co | Hi-Tech Pharmacal | Potency & Assay | Nationwide |
| Drug | CLASS II | Acetic Acid, Irrigation 3% Solution (1 Product) recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |