—#153214

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K051499
Affected lot / code info: Lot No. 16016790

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: US Distribution including MA and MD

Timeline

Recall initiated: 2017-02-20
Posted by FDA: 2017-02-28
Terminated: 2017-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153214. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.