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Recall Observatory FDA recall evidence

Device product

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

Z-1464-2017

February 20, 2017

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 76439
Status
Terminated
Classification
Class II
Quantity
1,200 units
Official record key
device-enforcement:Z-1464-2017

Official wording

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.

Code information: Lot No. 16016790

Distribution pattern: US Distribution including MA and MD

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.