—#153216

Product

MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets

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. 15045419 15075822 15086644 16036290 16056204 16075270 15086404 16067461 16046571 16045810

Why it was recalled

CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

CareFusion sent an Urgent Medical Device Recall Notification letter dated February 2017 to all affected customers inform them that CareFusion is recalling the MaxGuard Extension Set model codes ME20164, MP9009-C, MP9209, MP9254-C with multiple lot numbers. CareFusion has received reports of leaks occurring with the 0.2 micron filter. Customers were informed that leakages on an extension can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, underinfusion or air in line. Customers were instructed to discontinue use of the affected product and contact CareFusion for a replacement lot. 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. Customers were also instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2017-02-20
Posted by FDA: 2017-02-28
Terminated: 2018-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153216. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.