FDA Device recall Z-0007-2017
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions
- FDA Device
- Class I
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class I recall of 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions by Baxter Englewood, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0007-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-08-24 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Englewood |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | All unexpired lots-Product Code: H93835 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0007-2017%22
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