CLASS I Device recall · Reported 12 Oct 2016 · FDA Enforcement Report
0.2 Micron Filter recalled by Baxter Corporation Englewood
Baxter Corporation Englewood is recalling 0.2 Micron Filter, distributed nationwide in the US. The recall was initiated on 24 Aug 2016 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0007-2017
- FDA event ID
- 75031
- Recalling firm
- Baxter Corporation Englewood, Englewood, CO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 24 Aug 2016
- FDA classified
- 6 Oct 2016
- Reported
- 12 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 24 Aug 2016 | Recall initiated by company | |
| 6 Oct 2016 | Classified by FDA | +43 days |
| 12 Oct 2016 | 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
Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.
Product as listed by the FDA
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Where it was distributed
Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
Questions about this recall
Why was it recalled?
Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.
Which lots are affected?
All unexpired lots-Product Code: H93835
Where was it sold?
Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
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.
More recalls from Baxter Corporation Englewood
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter, Rapidfill Syringe Strip For use recalled | Baxter Corporation Englewood | Packaging Defects | Nationwide |
| Device | CLASS II | Abacus SE (Single-Workstation Edition) and Abacus ME recalled | Baxter Corporation Englewood | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter, Self-Righting Syringe Tip Caps recalled | Baxter Corporation Englewood | Other | Nationwide |
| Device | CLASS II | Self-Righting Luer Lock Tip Cap, Green recalled | Baxter Corporation Englewood | Foreign Material | 4 states |
| Device | CLASS II | Abacus 3.1, Pharmacy Calculator recalled by Baxter Corporation Englewood | Baxter Corporation Englewood | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,950| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |