RecallRadar

FDA Device recall Z-1464-2017

MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305

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

AgencyFDA Device
Recall numberZ-1464-2017
ClassificationClass II
Statusterminated
Initiated2017-02-20
Published2017-03-22
Last updated2026-09-13 11:54 UTC
CompanyCarefusion 303
DistributionMA, 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_infoLot 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.