FDA Device recall Z-1464-2017
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 by Carefusion 303, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1464-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-20 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carefusion 303 |
| Distribution | MA, MD |
Product
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Reason
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.
Identifiers
| code_info | Lot No. 16016790 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1464-2017%22
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