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Terminated

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

FDA Recall Z-1464-2017 · Posted 2017-02-28

Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2017-02-20
Date Terminated2017-11-17
Product Quantity1,200 units

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.

Firm Action

An Urgent Medical Device Recall Notification letter will be sent to customers on February 20, 2017 to inform them that CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter model number ME3305 Lot Number 16016790. Customers are informed that CareFusion has received reports of separation and/or leakages between theY-connector and tubing. Customers are informed that leakages from an extension set can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266.

Root Cause

Process control

Distribution Pattern

US Distribution including MA and MD

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051499INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETMedegen Medical Manufacturing Services · 2005-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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