MaxGuard Extension Set with Injection Site and 0 — Class II medical device recall Z-1464-2017
Terminated recall by CareFusion 303, Inc., reported 2017-03-22, distributed in MA, MD. CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of report
| Recall number | Z-1464-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2017-02-20 |
| Classified | 2017-03-14 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2017-11-17 |
| Distributed | MA, MD |
| Quantity | 1,200 units |
| Reason classes | packaging |
| Lot numbers | 16016790 |
| Model numbers | ME3305 |
Product
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Reason for recall
CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
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-1464-2017. 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.