0 — Class I medical device recall Z-0007-2017
Terminated recall by Baxter Corporation Englewood, reported 2016-10-12, distributed nationwide. Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Mic
| Recall number | Z-0007-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Corporation Englewood, Englewood, CO, United States |
| Recall initiated | 2016-08-24 |
| Classified | 2016-10-06 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, DK, ES, FI, GB, NL, NO, PT, SE |
| Quantity | 202,647 |
| Reason classes | specification failure |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0007-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.